List of osteoporosis medications

Contents

Osteoporosis treatment gap comes at a high price

Clinical practice guidelines for osteoporosis treatment are sometimes confusing or conflicting and physicians as well as patients may have a poor understanding of the balance of benefits and risks with osteoporosis treatment. Even when physicians do have a good understanding of benefits and risks, they may lack the time and skills to communicate this effectively to patients.

Among the general confusion, it is easy for misconceptions to arise: there is a common misperception, for example, that osteoporosis is a normal part of ageing and not a treatable disease; patients who have had a fracture often do not appreciate the high risk of future fractures. There is also a common misconception among the general public that osteoporosis only affects women.

Fear of side effects

It has become common for patients with osteoporosis, including patients at high risk of fracture, to be more concerned about possible side effects of drugs than consequences of fractures and therefore to decline treatment. Fear of osteoporosis drugs was assessed in a recent study conducted by the US National Osteoporosis Foundation (NOF) with its “online community” of about 28,000 individuals, with 853 (about 3%) responding. Around 38% of respondents had been prescribed a medicine they did not take, with 79% of these stating that fear of side effects was the reason for not taking it. Also, around 43% of the respondents thought that the risk of side effects with osteoporosis treatment was greater than the benefit. The findings of the NOF survey are consistent with the clinical experience that many patients who might benefit from an osteoporosis medicine are afraid to take it. This raises the question: “Why are so many patients afraid of osteoporosis drugs?” There is no simple explanation, but there are some players contributing to the situation.

Media reports not always accurate

Sometimes, perhaps unwittingly and with the best of intentions, the news media contribute to patients’ fear of osteoporosis drugs. Media reports that are biased, incomplete, misinterpreted, or poorly understood could influence patient behaviour. For example, the Women’s Health Initiative (WHI), a clinical trial involving hormone replacement therapy in postmenopausal women, received extensive international media attention. In a subsequent survey evaluating the effects of media coverage’s impact on the behaviour of women taking hormone replacement therapy, it was found that many women inappropriately changed therapy (stopping oestrogen-only therapy when the reported study was for combination oestrogen plus progestin) based on a misunderstanding of media coverage about the WHI. It also revealed that those who changed therapy were less likely to trust their physicians to provide information about the WHI. It was concluded that media reports had a significant influence on patients making treatment decisions that may not have been in their best interests. Media reports of adverse effects in osteoporosis treatment have been noted, concerning particularly bone density testing and bisphosphonate prescriptions, with evidence of an increase in fracture-related death when patients stop treatment after frightening news reports have appeared.

Dr Google

The NOF survey found that almost all patients look beyond doctors for information about a new treatment before starting it, with the internet being the most common information source. Media reports, found on the internet, television, and print media, as well as anecdotal experiences of friends and relatives also influence patient decisions. Reports from these sources may be alarming, since they usually focus on bad news surrounding possible side effects of medicines. The benefit of treatment — which in the case of osteoporosis would be no fracture — is not considered newsworthy. It is the perception of risk rather than the probability of harm that is most disturbing to patients. A report of a very rare event, such as osteonecrosis of the jaw or atypical femur fracture, may strike terror in the heart of a patient who is considering osteoporosis treatment, even though the likelihood of it happening is extremely low and the benefit for fracture risk reduction is great.

Pharma and government

There is often confusion and misunderstanding over the meaning of ‘side effect’ and its use in educational literature provided by pharmaceutical manufacturers. A reasonable person might think that a medicine’s side effect is an undesirable medical occurrence caused by the drug. However, the term ‘side effect’ is often commonly used to describe an adverse event reported in a clinical trial that is numerically greater in the treatment group compared with the placebo group, without regard to the magnitude of the difference, biological plausibility, or causality. Trivial numerical differences in event rates may be misconstrued as representing a causal relationship.

Pharmaceutical companies contribute to patients’ concerns about drugs, perhaps owing to concern of litigation or responses to regulatory agencies. As an example, an industry-sponsored website for denosumab (Prolia; Amgen) provides “important safety information” for patients. Here it states: “The most common side effects of Prolia are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.” This warning might lead a female patient with chronic back pain to believe that this would be a bad drug for her. However, an examination of the data from denosumab phase III registration trial, called FREEDOM, in which 7,868 women with postmenopausal osteoporosis were randomised to receive either denosumab or placebo, shows a different picture. The prescribing information derived from FREEDOM shows that 1,347 women in the denosumab group and 1,340 women in the placebo group were reported to have back pain — a difference of seven women out of thousands. As such, the evidence shows that back pain is common in women with postmenopausal osteoporosis; it does not show that denosumab causes back pain. There are similar discordances between the other stated “most common side effects” with denosumab and clinical trial data. Likewise, there are differences between events labeled as “side effects” and causal relationships with other osteoporosis drugs.

Communicating with patients

One of the greatest challenges in understanding drug safety is separating the ‘signal’ from the ‘noise’ in a time of information overload with a mix of sources of variable reliability. Healthcare providers, who are often unfamiliar with actual clinical trial data, may not have the time or the skills to discuss the many safety concerns that patients may have. There are also inherent uncertainties in applying clinical trial data to the care of individual patients and the complexities of understanding and communicating the balance of benefits and risks. Very rare side effects may not occur in a clinical trial, and only be recognised through post-marketing reports.

A way forward

Fear of taking osteoporosis drugs must be considered in the context of each individual patient, with appreciation that reluctance to take medicines may be irrational but real. The patient’s concerns should be discussed and misperceptions should be corrected in a non-threatening environment. A patient who is well informed is best able to make wise treatment decisions. Mainstream media have a responsibility to produce balanced reports that identify risks in proportion to benefits of treatment, showing absolute risk rather than relative risk, and describing the magnitude of the risk for different patient populations, doses, and duration of therapy. Patients should seek reliable information sources from academic institutions and non-profit professional societies, usually identified online with website URLs ending in ‘.edu’ or ‘.org’, and be cautious of websites that promote the sale of a product.

Pharmaceutical companies and regulatory agencies should use terminology for describing ‘side effects’ that conveys useful information to prescribers and patients, distinguishing what is likely to be clinically relevant from what is trivial. And finally, all healthcare professionals must take the time to become fully knowledgeable about the drugs they prescribe or dispense, and learn to communicate effectively the balance of benefits and risks. If a patient decides not to take the treatment, despite overwhelming evidence that treatment is effective and safe, they should not be abandoned. Periodic monitoring to reassess fracture risk and treatment strategies is appropriate, along with further discussion of the balance of benefits and risks of treatment.

E Michael Lewiecki is director of New Mexico Clinical Research and Osteoporosis Center, clinical assistant professor of medicine at University of New Mexico Health Sciences Center, and director of bone health ECHO in Albuquerque, New Mexico, United States. Correspondence to: [email protected]

New treatment for osteoporosis provides better protection against fractures

“With the new treatment, we could offer significantly better protection against fractures and could thereby help many patients with severe osteoporosis,” says co-author of the study Mattias Lorentzon, Professor of Geriatrics at the Institute of Medicine, Sahlgrenska Academy, and Senior Physician at Sahlgrenska University Hospital.

Many patients with severe osteoporosis and a high risk of fractures often cannot regain their original bone strength. They continue to have fractures even with treatment according to current standards with alendronate in tablet form every week.

Alendronate increases bone density by slowing the breakdown of bone and thereby decreasing the risk of fractures by 20-50 per cent. Many people with osteoporosis, especially elderly women, nonetheless continue to suffer broken bones, sometimes just by falling from a standing position. The fractures lead to disability and suffering, and with hip and vertebral fractures, often premature death.

The current study included 4,093 women, of an average age of 74 years, with osteoporosis and previous fractures. They were randomly allocated to 12 months’ treatment with either alendronate or the new medication romosozumab, an antibody that blocks the substance sclerostin, which slows the new formation of bone. Treatment with romosozumab thereby leads to rapid new bone formation. After the first 12 months, all patients received alendronate for 12 months.

The risk of vertebral fracture in the course of the study proved to be 48 per cent lower for those who received romosozumab compared with the group that received alendronate the whole time. The proportions suffering fractures in the two groups were 6.2 per cent and 11.9 per cent, respectively.

The risk of a clinical fracture, such as an arm or leg fracture, was 27 per cent lower in the group that received romosozumab. Here, the proportions suffering fractures in the different groups were 9.7 per cent and 13.0 per cent, respectively.

The proportion of side effects and serious side effects was generally just as common in both of the treatment groups. However, it was observed that serious cardiovascular events, such as heart attack or stroke, occurred in 2.5 per cent of the patients that received romosozumab compared with 1.9 per cent in the group that received alendronate during the first 12 months of the study.

According to Mattias Lorentzon, the safety aspects of the new medication need to be studied further. However, an earlier study of nearly twice the size showed that romosozumab does not provide a greater risk of cardiovascular events compared with a placebo.

“With romosozumab in the treatment arsenal, we could prevent many fractures among the high-risk patients,” he concludes.

Drugs for osteoporosis (used to treat and prevent fractures)

It’s likely that you’ll need pain relief medications while the fracture heals, for example:

  • painkillers (analgesics), such as paracetamol, codeine and occasionally morphine
  • non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen.

Prevention of fractures

A number of specific treatments are available to reduce the risk of further fractures. You’re likely to have a bone density scan before you start treatment, although this may not be needed, for example if you’re 75 or over. Once you’ve started treatment your bone density, and possibly other aspects of your health, may be monitored.

Treatments to reduce the risk of fractures work either by slowing down the breakdown of old bone material, or by speeding up the process of bone renewal, or a combination of both.

Bone renewal is a slow process so it’s important to continue treatment as your doctor advises – even though you won’t be able to feel whether it’s working.

Because longer-term treatment can sometimes have side-effects your doctor may suggest a break from your treatment after 3–5 years. The benefits of osteoporosis treatment last a long time so these won’t be lost if your doctor does suggest a ‘treatment holiday’.

Treatments to reduce the risk of osteoporotic fractures include:

  • calcium and vitamin D
  • bisphosphonates (alendronate, risedronate, ibandronate, etidronate, zoledronate)
  • teriparatide and parathyroid hormone
  • raloxifene
  • calcitonin
  • denosumab
  • hormone replacement therapy (HRT).

Strontium ranelate

This drug, which was produced under the brand name Protelos, was discontinued in 2017 but is now being produced again under the brand name Aristo. We will have further information on this drug soon.

If you were previously taking Protelos, you may want to speak to your doctor about Aristo.

5 Common Osteoporosis Drugs: Safe or Dangerous?

“When I joined Mayo Clinic in 1988, basically we could offer patients estrogen and very little else other than calcium or vitamin D. Now we’ve got all of these different options that can be tailored to the needs of a given patient depending on their preferences, the severity of the disease, their age, and other risk factors,” says Dr. Khosla.

Risk of Developing Osteoporosis Rises With Age

As with many chronic diseases, simply getting older puts you at higher risk of osteoporosis. Currently, 1 in 4 American women over age 65 and 1 in 20 men in that age range have osteoporosis, according to the Centers for Disease Control and Prevention (CDC).

In adults, bones go through a continuous process of breaking down and building up again, called remodeling. Osteoblasts create bone and osteoclasts break down the tissue in bones and release the minerals into the blood.

The hormones androgen and estrogen play a role in the balance of breaking down and rebuilding bone. As people get older and these hormone levels drop, the bone is removed or damaged faster than the body is able to replace it, leaving bones weakened and vulnerable to fracture.

Unhealthy lifestyle habits, such as smoking, drinking, and lack of exercise also raise the risk of developing osteoporosis, as does the long-term use of certain types of medication, including corticosteroids.

Fractures Prevented Vastly Outnumber Serious Side Effects

Depending on the body part (whether it’s the spine or the hip or another bone in the body), taking an osteoporosis medication will reduce the chances of fracture anywhere from 50 to 70 percent — a substantial reduction in risk, says Khosla.

“The side effects are quite rare. In general, something on the order of 100 to several thousand fractures from osteoporosis would be prevented for every serious side effect that was induced from these drugs. I find putting the risks and benefits in this context conveys why it’s important to take the medication,” says Khosla.

Here’s a rundown of the benefits and risks of many commonly prescribed osteoporosis treatments:

1. Bisphosphonates Slow Bone Loss

Bisphosphonates work by reducing osteoclast activity, which slows the turnover of bone or removal of old bone and improves bone strength and bone density. “These drugs have a long track record; we know a lot about them,” says Khosla.

Some bisphosphonates, such as Fosamax (alendronate) and Actonel (risedronate), are taken as a daily or weekly tablet, while Boniva (ibandronate) is taken monthly to prevent and treat osteoporosis. Reclast (zoledronic acid) is taken intravenously once a year to treat osteoporosis and every two years to help prevent it.

“There’s a lot in favor of using a bisphosphonate,” says Khosla. According to a meta-analysis published in February 2017 in the Journal of Bone Metabolism, bisphosphonate use decreased the risk of overall osteoporotic fracture by over 60 percent.

While the common side effects of bisphosphonates — including bone, joint, or muscle pain, as well as nausea, difficulty swallowing, and heartburn for the oral drugs — may be bothersome for some, it’s the rare side effects of osteonecrosis of the jaw and atypical femoral fracture that have scared many people away from taking medication to prevent or treat osteoporosis.

Osteonecrosis of the Jaw

The risk of osteonecrosis of the jaw that comes with bisphosphonate use is very low, according to the National Center for Biotechnology Information.

Osteonecrosis of the jaw occurs when the jaw bone is exposed and begins to starve from a lack of blood. Although the risk for this adverse event is low for all bisphosphonates, it is mostly reported with Reclast and pamidronate, an older bisphosphonate that’s given intravenously. Doctors sometimes use these therapies in very potent doses to prevent fractures and bone loss associated with cancer or cancer treatments, according to American Bone Health.

There are ways to minimize the risk of jaw osteonecrosis, including getting a dental exam before starting therapy on a bisphosphonate, practicing good dental hygiene, and avoiding invasive dental procedures while taking the medication.

Atypical Femoral Fracture

Bisphosphonates can also carry a risk of atypical femoral fracture, which starts when the outer rim of the femur (thigh bone) starts to weaken. Unlike stress fractures or other bone breaks, the bone cracks from just normal activity. An aching pain in the groin or thigh can be a warning signal that this may be happening, according to American Bone Health. With no intervention, the crack continues to grow and eventually the thigh bone breaks in two.

In a meta-analysis of 14 studies published in January 2017 in the Journal of Nutrition, Health & Aging, the incidence of atypical femoral fracture was low, ranging from 3.0 to 9.8 cases per 100,000 patient-years. Most, though not all, of the fractures occurred in bisphosphonate users.

Drug Holiday to Minimize Risks

The longer a person takes a bisphosphonate, the greater the risk for both jaw necrosis and atypical femoral fracture, especially after three years. In an effort to minimize the risk as much as a possible, a drug holiday is recommended. A drug holiday is a temporary stop of a medication (in this case, bisphosphonate) in an effort to prevent the potential side effects.

The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) guidelines recommend a holiday after five years of oral and three years of intravenous bisphosphonate treatment for people with moderate fracture risk and after 10 years of oral and six years intravenous bisphosphonate treatment for people at a higher fracture risk.

A study published in December 2018 in Endocrine Practice found that 15.4 percent of patients who take a break from their bisphosphonate treatment had a bone fracture. The study authors recommended that people who have a high risk of fracture be closely followed by their doctor during drug holiday.

RELATED: Even During a ‘Drug Holiday,’ Osteoporosis Patients Should Be Monitored

2. Parathyroid Hormone Builds Bone Back Up

Parathyroid hormone drugs include Forteo (teriparatide) and Tymlos (abaloparatide), which help the body build new bone. Both drugs require patients to inject themselves on a daily basis for 18 months to two years.

“These drugs are generally reserved for people with multiple fractures or those who are continuing to lose bone or having fractures on a bisphosphonate, or a patient with very severe osteoporosis,” says Khosla.

These are drugs that can build the bone back up and potentially reverse the osteoporosis, he says. People who take parathyroid hormone drugs had significantly fewer new vertebral fractures.

The long-term safety of these drugs is still unclear, which is one reason a person can only take them for two years. During the testing of both of these drugs, they were associated with an increased risk of bone cancer in animal studies.

3. Human Monoclonal Antibodies: Each Works Differently

Human monoclonal antibodies for osteoporosis include Prolia (denosumab) and the new drug Evenity (romosozumab).

Prolia is given by injection every six months, and it works by inhibiting the maturation of osteoclasts, which protects bones from degrading and slows the progression of the disease. Prolia significantly reduces vertebral, hip, and nonvertebral fracture at one, two, and three years, though it also carries a very slight risk of osteonecrosis of the jaw and atypical femoral fracture.

Evenity is a monoclonal antibody that represents a breakthrough in osteoporosis treatment: It both builds bones and decreases bone loss. Injected once a month for a year, it works by blocking sclerostin, a protein involved in bone remodeling, and it can be used in addition to other osteoporosis drugs as a bone-building medication. In clinical trials, one published in the March 2019 issue of the Journal of Bone and Mineral Research and one published in October 2017 in The New England Journal of Medicine, Evenity reduced the risk for fracture by more than 70 percent, and study participants had increases in bone density in their spines of around 15 percent — a very significant margin.

Evenity carries a warning due to an increased risk of heart problems. In one of the two studies used for FDA approval, cited above, Evenity was associated with an increased risk of cardiovascular death, heart attack, and stroke. These events occurred in 50 of 2,040 patients, or 2.5 percent taking Evenity, compared with 38 of 2,014, or 1.9 percent, taking Fosamax.

4. Estrogen Promotes Bone Production

Estrogen replacement therapy used to be the only FDA-approved treatment for the prevention of osteoporosis because of the hormone’s role in producing bone. Often women start taking estrogen for treatment of severe hot flashes around the time of menopause, says Khosla. “They feel better, and they also have the added benefit that the estrogen is helping prevent fractures and potentially other conditions, like diabetes,” he says.

However, “there is a concern about the increase for breast cancer risk and cardiovascular events, including heart disease, stroke, and blood clots,” says Khosla. After weighing the benefits and risks, some women choose to take estrogen on a short- or long-term basis for quality of life issues, he says.

Estrogen is not used to treat men who have osteoporosis, although testosterone may be used in men with low testosterone levels.

5. Calcitonin Less Effective Than Newer Options

Calcitonin is a very old drug, says Khosla. “It used to be given by injection and more recently by nasal spray, but it’s not prescribed that much anymore,” he says. “It’s not as effective as many of the other drugs that are available now, and there was some concern a number of years ago about some increase in cancer risk that’s associated with long-term use of calcitonin.”

For Most, Osteoporosis Treatment Benefits Outweigh Risks

“There’s been remarkable progress made in terms of addressing the disease, and now the real challenge is implementation: getting the message out that we have these options,” says Khosla. “When these drugs are used appropriately, they are safe as compared with many other things that we do in medicine. They will provide a lot more benefit than the risks that they pose,” he says.

There are many patients who would benefit from taking medication for osteoporosis, but they’re either not being prescribed the drugs, or they’re not taking them because of concerns about these rare side effects, says Khosla. “I think within the clinical community of physicians who care for patients with osteoporosis, we’re trying to find ways to better convey the benefit-to-risk ratio of these osteoporosis drugs so that people are appropriately treated when they need to be.”

Ask the Osteoporosis Experts

To make an appointment with Andrea Sikon, MD please call 216.444.3024 or call toll-free at 800.223.2273, ext. 43024. You can also visit us online at clevelandclinic.org/obgyn.

A remote second opinion may also be requested from Cleveland Clinic through the secure eCleveland Clinic MyConsult Web site. To request a remote second opinion, visit eclevelandclinic.org/myConsult

This information is provided by Cleveland Clinic as a convenience service only and is not intended to replace the medical advice of your doctor or health care provider. Please consult your health care provider for advice about a specific medical condition. Please remember that this information, in the absence of a visit with a health care professional, must be considered as an educational service only and is not designed to replace a physician’s independent judgment about the appropriateness or risks of a procedure for a given patient. The views and opinions expressed by an individual in this forum are not necessarily the views of the Cleveland Clinic institution or other Cleveland Clinic physicians. ©Copyright 1995-2012 The Cleveland Clinic Foundation. All rights reserved.

About 10 million adults in the United States over the age of 50 have osteoporosis. Osteoporosis is a condition defined by low bone density, which increases the risk of hip fractures and spinal fractures. Research has shown that the risk of death after hip fracture may be around 10% at 30 days after the fracture, and 27% at 1 year after the fracture. This is one of the reasons why preventing or treating osteoporosis is so important.

The most commonly prescribed osteoporosis medication is alendronate (Fosamax). Alendronate treats and prevents osteoporosis in post-menopausal women, and reduces the risk of vertebral and hip fractures in women who already have osteoporosis. It belongs to a class of medications called bisphosphonates, which also includes the osteoporosis medications risedronate (Actonel) and ibandronate (Boniva).

Unfortunately, there is a lot of misinformation surrounding alendronate. This can lead to fear and confusion over a drug that is generally safe and effective. Let’s take a look at the facts and myths about alendronate’s risks below.

Alendronate facts

Esophagus irritation

Alendronate makes the stomach more acidic, and that extra acidity can irritate the esophagus, the tube connecting your mouth to your stomach. This can cause inflammation (esophagitis) and ulcers. The good news is that these issues can be prevented by taking the medication on an empty stomach with a full glass of water, and avoiding lying down for 30 minutes after that.

Pro tip: Alendronate is usually prescribed as a pill, but it also comes in a liquid solution and an effervescent formulation (Binosto). These options may be less irritating on the esophagus, stomach, and intestines, and you can sit or lay down right after taking it.

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Low risk of dead jawbone

This is a very rare side effect of bisphosphonate medications in general, but many of my patients ask me about it when I prescribe alendronate. Jaw osteonecrosis (“dead jawbone”) is when the jaw bone becomes exposed and is deprived of blood circulation. In most cases, it happens in people with cancer who are given the bisphosphonate zoledronic acid by intravenous (IV) infusion. It is very rare in people who do not have cancer.

The risk may increase if you have dental surgery and have been taking alendronate for more than 4 years. According to the American Association of Oral and Maxillofacial Surgeons, if you’ve been taking alendronate for less than 4 years, you can continue taking it and go ahead with surgery. But if you’ve been taking it for more than 4 years, your surgeon will ask you to wait for at least 2 months after stopping alendronate before you have surgery.

Low risk for atypical femur fractures

Alendronate may cause a very slight, increased risk for atypical femur fractures, a specific type of fracture that begins on the outside of the thigh bone (femur) due to stress from normal daily activities. It only occurs in people who have taken alendronate long term (more than 5 years), but even then, the risk is very low.

Why does it happen? Our bones are constantly broken down and rebuilt to repair small fractures that occur day to day, but bisphosphonates prevent the breaking down part (known as bone resorption). Over time, this can lead to an increased risk of atypical femur fractures.

Alendronate myths

Esophageal cancer

Simply put, alendronate is not associated with an increased risk of esophageal or any gastrointestinal cancers. That said, people with existing esophageal disease (like Barrett’s esophagus) are advised to avoid alendronate.

Atrial fibrillation

Even long-term use of alendronate does not increase the risk of atrial fibrillation.

How long is too long with alendronate?

Recent guidelines suggest that 4 years may be the magic number when it comes to alendronate. Four years of Alendronate has been shown to decrease the risk of hip and spine fractures without considerable risk of side effects that could lead to brittle bones. After 4 years, a break from alendronate and a close eye on your bone health for the next few years is recommended.

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Dr. O

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  • Department of Health

    FDA-Approved Medications for Osteoporosis Treatment

    Treatment of osteoporosis should always include: a well-balanced diet, getting the right amounts of calcium and vitamin D, being physically active every day, not smoking, quitting if you do smoke, limiting the amount of alcohol you drink, and taking safety precautions to prevent falls. However, if you are diagnosed with osteoporosis, these important lifestyle changes are often not enough; medication may be needed to stop further bone loss and to prevent broken bones. Your health care provider will review your medical history and assess your risk factors to determine your need for osteoporosis medication. It is important that you and your health care provider discuss the benefits and potential risks of any medication, taking into consideration your medical history.

    Medicines to Treat Osteoporosis

    The Federal Drug Administration (FDA) has approved the following medications for osteoporosis treatment. There are two dierent categories of medications: antiresorptive and anabolic.

    Antiresorptive medication slows down the breakdown of bone. This helps to prevent bone loss and lower the risk of fracture.

    Bisphosphonate antiresorptive medications:

    • alendronate -generic medication (Brand name: Fosamax™, Fosamax™ Plus D)
    • risedronate (Brand name: Actonel™, Actonel™ with Calcium)
    • ibandronate ( Brand name: Boniva™ )
    • zoledronic acid (Brand name: Reclast™)

    Other antiresorptives:

    • estrogen therapy or hormone therapy
    • raloxifene (Brand name: Evista™)
    • denosumab (Prolial™ )

    Anabolic medication helps to make new bone, increases bone density and can also reduce the risk for a broken bone. Currently, the only FDA-approved anabolic medication is:

    • teriparatide (Forteo™)

    How often and how will I take my medication?

    The medication your health care provider recommends for you, will determine how it will be taken. Some medications come in pill form injection, or intravenous. How often you take your medicine will also vary for each medication.

    How can I get involved in deciding about taking a medication?

    Education is the key to helping you make choices necessary to achieve healthy bones and wellness for a lifetime. It is always important to discuss all of the potential benefits and risks of any osteoporosis medication with your health care provider. Before and during treatment with any osteoporosis medication, it is important to tell your health care provider and pharmacist about all of the medications you take, including prescription medications, herbal supplements, and vitamins. Take an active role in your bone health and discuss medication options with your health care provider.

    Contact Information

    NYSOPEP Resource Center
    Helen Hayes Hospital, West Haverstraw, NY
    845.786.4772

    Publication 1984, Version 2/2015

    What are bisphosphonates and why are they used in lupus treatment?

    Bisphosponates such as risedronate (Actonel), alendronate (Fosamax), ibandronate (Boniva), zoledronic acid (Reclast), and pamidronate (Aredia) are used to treat and prevent osteoporosis—or, bone thinning—which occurs when the bones lose calcium and other minerals that help keep them strong and compact. This condition can lead to fractures, bone pain, and shorter stature. Everyone is at risk for osteoporosis as they age, and women experience a greater risk of the condition after menopause. However, studies have shown that people with lupus are at an increased risk for osteoporosis due to the inflammation they experience with the disease. Certain medications taken by lupus patients also increase the risk of osteoporosis, especially corticosteroids such as prednisone.

    How do bisphosphonates work?

    Your bones are constantly remodeling in a process that removes old bone cells and deposits new ones. In people with osteoporosis, the bones lose minerals faster than they can be regenerated. Bisphosphonates help prevent your bones from losing calcium and other minerals by slowing or stopping the natural processes that dissolve bone tissue. In doing this, they help your bones remain strong and intact. If you have already developed osteoporosis, these medications may slow the thinning of your bones and help prevent bone fractures (broken bones). In fact, studies have shown that alendronate (Fosamax) and risedronate (Actonel) can lower your risk of fractured vertebrae—bone segments that make up your spine—by 50%. Similar studies demonstrate that these medications can lower the chance of breaking other bones by 30-49%.

    What are the usual doses of bisphosphonates, and what should I remember while taking these medications?

    Most bisphosphonates are taken anywhere from once a week to once a month. All of these medications come in tablet form except for zoledronic acid (Reclast), which is given intravenously (IV) once per year. Both women and men may take bisphosphonates.

    You should take these medications in the morning with a full glass of water at least a half-hour before eating, drinking, or taking other medications. Do not lie down for 30 minutes after taking the medication.

    What else can I do to maintain strong, healthy bones and lower my risk of developing osteoporosis?

    It is important for you to take other steps to help keep your bones healthy and strong. Exercise and movement are important for the health of your bones, joints, and muscles and may lower your risk of osteoporosis. Walking, stretching, yoga, and other activities will help ward off bone thinning and muscle loss. Studies have shown that people who live more sedentary lifestyles are at an increased risk of developing osteoporosis. In addition, your doctor will most likely recommend that you take calcium and vitamin D supplements while taking bisphosphonates, since vitamin D helps your body to absorb calcium. It is important that you also try to eat foods rich in calcium, such as milk, light ice cream/frozen yogurt, cottage cheese, pudding, almonds, broccoli, fortified cereal, oranges, yogurt, hard cheese, soybeans and soymilk, navy beans, oysters, sardines, and spinach.

    Your doctor will most likely recommend that you get a bone density scan, or DEXA scan, every two years to evaluate your response to treatment. The test takes only about fifteen minutes to perform and can provide your doctor with valuable information regarding the health of your bones.

    What are the side effects of bisphosphonates?

    Potential side effects of these medications include:
    • Heartburn, stomach pain, and throat irritation
    • Headache
    • Muscle and joint pain
    • Flatulence (constipation, diarrhea, gassy stomach)
    • Dysphagia (difficulty swallowing)
    • Pain or burning under the ribs or in the back
    • Jaw pain, numbness, and swelling
    • Dizziness, weakness
    • Allergic reaction
    • Reclast may be linked to an irregular heartbeat called atrial fibrillation.

    In addition, some people have reported problems with bone healing (specifically, osteonecrosis of the jaw), especially after dental extractions or implants. Talk to your doctor if you plan to have this sort of treatment, since she/he will most likely recommend that you stop taking these medications before the event and begin taking an antibiotic. Also talk to your doctor if any of the side effects you experience are particularly bothersome.

    Who should not take bisphosphonates?

    The following people should not take bisphosphonates unless your doctor approves the treatment:

    • Pregnant women or women planning to become pregnant
    • People with severe kidney problems
    • People with esophagitis (inflammation of the esophagus, the tube down which food travels from your mouth to your stomach)
    • People who are currently taking parathyroid hormone (Forteo), although exceptions may be made.

    Talk to your doctor if you have low blood calcium (hypocalcemia), a vitamin D deficiency, kidney disease, or an ulcer in your stomach or esophagus, since you may not be advised to use these medications.

    What if I am taking other medications?

    Certain medications can affect how your body deals with bisphosphonates. Your lupus treatment may involve several medications, but you should still tell your doctor if you are taking any other medicines—prescription drugs, over-the-counter medications, supplements, and vitamins—especially NSAIDs, such as ibuprofen (Advil, Motrin), celecoxib (Celebrex), naproxen (Aleve, Naprosyn), meloxicam (Mobic), and diclofenac (Voltaren, Cataflam). In addition, antacids and other supplements that contain aluminum, calcium, and magnesium can interfere with how your body absorbs bisphosphonates, so you should not take these medicines for at least 30 minutes after taking your bisphosphonate tablet.

    Osteoporosis treatment has radically changed in a relatively short period. In the early 1990s, women had few treatment options. Now, there are many different types of treatments available. This has created a dilemma for women trying to decide which, if any, of these medications they need. Women want to know when it is appropriate to take a drug for osteoporosis, and which treatments are safest and most effective. History has shown that preventing loss of bone mineral density in women who are otherwise at low risk of experiencing a fracture is a dangerous strategy.

    Instead, the National Women’s Health Network believes that treatment should be focused on women who are known to be at high risk of fracture due to prior fractures, long-term corticosteroid use, or other known risk factors. Though drugs can be appropriate for women with severe osteoporosis who are at high risk of fracture, they are not the solution for everyone. Overall, efforts should focus on promoting bone health for all women and preventing fractures through a variety of methods for those at risk.

    We’ve developed this fact sheet to help women understand what treatment options exist, what the side effects and risks are, what evidence supports their efficacy, and how to adopt non-drug approaches to preventing fracture. We hope this tool will help empower women to have conversations about osteoporosis with their providers, make informed decisions about whether they need drug treatment, and determine which drugs makes the most sense for their unique circumstances.

    First Line Treatments

    Bisphosphonates

    Bisphosphonates are commonly prescribed for osteoporosis treatment and prevention. The FDA has approved many bisphosphonates to prevent bone loss and fractures in post-menopausal women: alendronate (brand name Fosamax), etidronate (brand name Didronel), ibandronate (brand name Boniva), risedronate (brand name Actonel), tiludronate (brand name Skelid), pamidronate (brand name Aredia) and zoledronic acid (brand names Reclast and Zometa). Some are taken daily; others are formulated for weekly, monthly or yearly use. Bisphosphonates decrease the rate that bone is destroyed, a process called resorption, by stopping the activity of the cells that cause bone breakdown, called osteoclasts. This slows down the rate of bone loss. The drugs are also incorporated into newly formed bone and can persist in them for years, so the effects last well beyond the final treatment.

    The way bisphosphonates are prescribed has changed as our data has improved. The National Women’s Health Network expressed strong concerns with the old “screen early, treat indefinitely” approach to osteoporosis that drug companies heavily promoted. This approach, which was routine in the 1990s and 2000s, led many healthy women to take bisphosphonates for long periods of time. In May 2012, the FDA expressed concerns about the safety and effectiveness of bisphosphonate use beyond 5 years. The agency told manufacturers to inform women that long-term use may not be beneficial. This advice was based on studies that showed women who took bisphosphonates for 6 or more years had higher fracture rates and suffered more complications than women who took bisphosphonates for 3-5 years.

    Although many clinicians and pharma-sponsored education campaigns conflate prevention and treatment, the NWHN thinks that it is important for people considering bisphosphonates to understand how the effectiveness differs based on individual’s bone health. These drugs have been shown to reduce the risk of a hip fracture in women who have been diagnosed with osteoporosis because of a previous facture, or very low bone density. However, they have not been shown to prevent hip fractures in women who have been told that they have osteopenia. They do prevent vertebral fractures, including in women who have not previously fractured. It’s understandable that women may want to prevent vertebral fractures, which can be painful and debilitating. However, women should be aware of these drugs have side effects and rare but serious risks.

    There have been numerous reports of unusual fractures in the thighbones of otherwise healthy women that took an inordinately long time to heal. Other women experienced severe bone, joint, and/or muscle pain. The FDA advises patients with such pain to consider discontinuing the drug, which usually causes the pain to go away. The jaw tissue of some women taking bisphosphonates dies (jaw necrosis), which can necessitate removal of an area of the jaw bone. Bisphosphonates also can cause severe heartburn and ulcers and damage the stomach and esophagus if not taken in a very careful regimen (on an empty stomach, with a full glass of water, while sitting upright for up to thirty minutes).

    For many years, the risks of bisphosphonates were unknown, and many healthy women who took these drugs experienced unnecessary side effects. We now have a much better understanding of the risk bisphosphonates pose, and have a few strategies to mitigate them. We also understand which women will benefit most from treatment. For women who have already had a serious fracture and are looking to prevent a second or third fracture, the benefits of bisphosphonates may well outweigh the risks. For women with osteopenia who have never fractured, the NWHN seriously questions the benefit of bisphosphonate treatment.

    Monoclonal Antibodies

    Denosumab (brand name Prolia) is an osteoporosis medication that uses human monoclonal antibody. Approved in 2010, this drug works by targeting and inactivating osteoclasts to stop natural bone breakdown, or resorption, processes. Denosumab is given in a subcutaneous (just below the skin) injection twice a year. This treatment is intended for women with severe osteoporosis who are at high risk of fracture. For those women, a common first-line treatment plan will include two years of denosumab followed by three to five years of bisphosphonate use. This is because the fracture-preventing, bone-density-building benefits that densoumab confers are quickly lost if not followed by several years of bisphosphonates.

    Denosumab has proven effective at building bone density and reducing spine and hip fractures. However, it carries a risk of serious side effects. Denosumab’s cellular target in bone also exists in the immune system. This has led some women taking denosumab to experience serious infections requiring hospitalization (e.g. heart infections), making this a poor option for those with weakened immune systems. Since denosumab and bisphosphonates target the same biological pathways, it is not surprising that denosumab also causes disintegration of the jaw, called osteonecrosis. It also may cause the same atypical femur fractures as bisphosphonates, though the causal relationship is less certain for this potential outcome. The treatment is also extremely expensive, costing thousands of dollars a year. Some insurance companies are reluctant to cover denosumab due to the very high price.

    The NWHN is concerned that for most postmenopausal women the benefit of denosumab does not outweigh the risks. We recommend that women seeking osteoporosis treatment approach denosumab with caution.

    Second-Line Treatments

    Peptide Hormones

    Two other hormones have been approved to treat osteoporosis: teriparatide and abaloparatide. Teriparatide (brand name Forteo) is a lab-made derivative of human parathyroid hormone (PTH), and abaloparatide (band name Tymlos) is a derivative of human parathyroid hormone-related protein. In the body, parathyroid hormone and parthyroid- hormone-related protein stimulate the production of new bone tissue. The drugs mimic this activity. Both drugs are administered through injections into the fatty tissue, usually in the abdomen or thigh.

    These drugs have been shown to stimulate new bone formation and prevent fractures in women with osteoporosis. However, the absolute reduction in fractures in clinical trials of these drugs were very small, between 2-4%. In addition to limited efficacy, these drugs have serious safety concerns. The drugs carry a label warning about bone cancer, or osteosarcoma. This is because teriparatide caused bone cancer in animals during early testing. Other side effects include nausea, dizziness, leg cramps, dangerously high calcium levels and vomiting. The recommended length of treatment for these drugs is two years; after this point, the effectiveness of the drug plateaus while the risks increases. It’s also very expensive, up to $19,500 per year, and some insurance companies are reluctant to cover it. Given the expense, the safety concerns, and the lower efficacy, teriparatide and abaloparatide are reserved for women with severe osteoporosis and are usually only prescribed when other treatment options have been deemed inappropriate or insufficient.

    Third-Line Treatments

    Menopausal Hormone Therapy & Selective Estrogen Receptor Modulators (SERMs)

    Menopause hormone therapy refers to the drug therapies of estrogen and progestin or estrogen alone that used to be routinely prescribed to women around the time of menopause. One of the justifications for practice was data showing that menopause hormone therapy could reverse bone loss and prevent hip fracture. However, the Women’s Health Initiative revealed that these hormones are dangerous. They increase the risk of breast cancer, heart attack, blood clots, and stroke.

    Selective Estrogen Receptor Modulators (SERMs) are compounds that act like estrogen on some tissues (e.g. bone tissue) and have an anti-estrogen effect on other tissues (e.g. breast and sometimes uterine tissue). The Food and Drug Administration (FDA) has approved raloxifene (brand name Evista) to prevent and treat osteoporosis. Although raloxifene has been shown to reduce the risk of vertebral (spinal) fracture, it has no impact on hip or wrist fractures. The drug is also associated with serious risks, including life-threatening blood clots.

    Although these medications used to be a relatively common treatment option for osteoporosis, we agree with the 2017 updated guidelines from American College of Physicians that recommend against using either menopause hormone therapy or SERMs to treat osteoporosis.

    Calcitonin

    Calcitonin (brand names Fortical or Miacalcin; not the same as calcium supplements) has been shown to prevent fractures of the spine but not of the hip and wrist. It is approved to treat women with osteoporosis, but its approval was based on weaker evidence than more recently approved drugs, and its use is not generally recommended. Women who take calcitonin must watch their intake of foods with high calcium levels (e.g. milk, cheese) as excessive calcium can be dangerous. Calcitonin is administered through a nasal spray; side effects may include nasal congestion and nausea. Although calcitonin is technically still available, it is considered obsolete due to safety concerns and low efficacy compared to other treatments.

    Non-Drug Alternatives

    Building Strong Bones

    There are many ways to treat or prevent osteoporosis that do not rely on drug treatment. Though non-drug alternatives probably won’t replace drug treatment for women with serious osteoporosis, all women and men can take steps to build strong bones and prevent falls to reduce their risk of fracture.

    It is important to ensure your body has the nutrients it needs. This means getting the daily recommended dose of vitamin B, which has been linked to muscle health, along with maintaining a healthy diet high in antioxidants. There are multiple ways to get the 700mg daily recommended dose of vitamin B. The nutrient is found in animal products like eggs, fish, poultry, and dairy, as well as in some cereals, rice, and plant-based dairy alternatives.

    Exercise is another critical way to maintain healthy bones. Studies have shown that exercise—especially weight bearing exercise regimens like walking, dancing, or running—leads to increased bone density. Tai Chi – an ancient Chinese practice that combines slow, deliberate movements, breathing exercises, and meditation – has been shown to be one of the most effective exercise regimens for increasing bone density and reducing fracture risk. An added benefit of exercise is that it increases strength and balance, which can reduce the risk of falling that leads to fracture.

    Fall Prevention

    Even the weakest bones are unlikely to break without some form of trauma. When an older adult breaks a bone, falls are often to blame. Falls contribute to over 95% of osteoporotic hip fractures. If you have been diagnosed with osteoporosis, reducing the risk of falls is an essential part of a comprehensive fracture-reduction strategy. Whether or not you choose to take medication, there are several methods to reduce your risk of falling and experiencing a fracture.

    Making your home “fracture-proof” is an excellent place to start. Studies show that taking steps like taping down the edges of rugs or mats, installing textured pads to showers and slippery floors, ensuring good lighting – especially in stairways – and wearing stable nonslip shoes around the house successfully reduce the risk of fracture. When you leave the house, wear nonslip shoes and be aware of slippery surfaces, especially in the winter when walkways can be icy.

    Consistent exercise, especially daily balance training, can help strengthen muscles that stabilize the body. Balance training exercises can be found online and done at home. Classes and programs also exist, and may be advisable for those who are frailer. Poor vision can lead to tripping, slipping, and possibly fracture. Getting regular vision checks and using prescribed eyewear is also important.

    Dizziness and fainting are common side effects of many drugs prescribed to older adults. Check the FDA label online or in the package insert to determine whether any drug you take can cause these side effects. Though you cannot predict how your body will respond to any given medication, taking the proper precautions, like sitting down when you feel dizzy or faint, can help you to avoid falls. It is also a good to schedule an appointment once a year with your primary care physician to review your mediations. These appointments, called “brown bag” appointments, involve bringing all the medications you take to the appointment in a bag and talking with your physician about which prescriptions could be stopped, or changed. The number of medications prescribed to older adults, especially those with chronic conditions cared for by multiple physicians, can be staggering and sometimes isn’t necessary. A brown bag appointment is not only a good health and safety measure, it could also help lower the dosage or even eliminate drugs that cause dizziness or fainting.

    The Bottom Line

    Think carefully about your own risk of experiencing a serious fracture and consider safety issues when deciding whether to take osteoporosis drugs. Don’t hesitate to ask your health care provider about the safety and efficacy of osteoporosis medications and whether non-drug alternatives might be just as effective, based on your personal history and current health status. For more information, visit the National Institutes of Health Osteoporosis and Related Bone Diseases Resource Center’s website.

    Contact Us

    The National Women’s Health Network is committed to ensuring that women have access to accurate, balanced information about osteoporosis. If you have a question you would like to ask NWHN, submit it on our weekly Q & A column “Since You Asked.” Stay informed about this issue by signing up for our e-alerts, and by connecting with us on Facebook , Twitter, and Instagram.

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