A Guide to Treatments for Osteoporosis

Osteoporosis is a decline in bone mass and density, making bones more fragile and susceptible to fracture. It occurs in both sexes but is most common in women who have gone through menopause.

Drug treatment can prevent broken bones in some women. But drugs are not always necessary and can cause harmful side effects, especially when treatment lasts longer than needed. You can get the most benefit from osteoporosis drugs with the least risk by learning who should take these drugs, which drugs to take and for how long.

Osteoporosis overview

Doctors diagnose osteoporosis by measuring bone mineral density with a simple X-ray test.[1] If a postmenopausal woman (or man over age 50) has a bone density that is much lower than that of an average young healthy adult, he or she is diagnosed with osteoporosis.[2],[3]

According to the U.S. Preventive Services Task Force, an independent panel of experts in evidence-based disease prevention, the following individuals should be screened for osteoporosis:

• Women aged 65 years or older.
• Women younger than 65 who have a bone fracture risk equal to or greater than that of a white woman age 65 or older.[4]

Some people with osteoporosis have identifiable underlying conditions that can cause low bone density, including vitamin D deficiency, gastrointestinal disease, chronic renal disease, chronic liver failure or immobility.[5] Drugs such as immunosuppressants, corticosteroids and anticonvulsants also may have adverse effects that lead to osteoporosis. Addressing these conditions and limiting use of these drugs may help to increase bone mass without taking osteoporosis drugs.

Nondrug steps to prevent fractures

The most serious risk from osteoporosis is hip fracture, which can lead to premature death and long-term disability.[6] It is important for all women to work to build and maintain strong bones to minimize this risk, regardless of whether they also need drug treatment. The key to strong bones throughout your life is eating a healthy diet and getting regular exercise. Weight-bearing exercise provides bones with a stimulus that enhances bone rebuilding. Sitting does the opposite: The bones receive no stimulus to rebuild, causing them to gradually lose mass over time.

In addition to exercise and good nutrition, you can help prevent fractures, even if you do not have osteoporosis, by taking steps to prevent falls. These include avoiding medications that cause dizziness, removing anything that might be a tripping hazard in the home and having your eyes checked annually to ensure good vision.[7] (For more on fall prevention, see "Falls in Elderly People: The Role of Blood Pressure Drugs.")

Fracture risk and treatment decisions

Low bone density is just one of many possible signs that your risk for fracture is increased. Other factors that may increase this risk include prior fractures, increased age, female gender, white or Asian race, low body weight, lack of exercise and low sun exposure.[8],[9],[10]

Some women with low bone density may not be at a high enough risk of fracture to need drug treatment and can treat the condition simply by following the steps listed above to build and maintain strong bones. However, for older men and women whose bone density is very low, particularly those who have experienced a fracture in the past, drug treatment often is beneficial.[11]

Doctors use a risk calculator — called the Fracture Risk Assessment Tool, or FRAX — to calculate fracture risk.[12] Many doctors will consider drug treatment if a patient’s overall risk is high, calculated as a 3 percent or more chance of hip fracture over the next 10 years.[13]

Bisphosphonates to treat osteoporosis

There are many kinds of drugs approved by the Food and Drug Administration (FDA) for treating osteoporosis (see table). Public Citizen’s Health Research Group recommends only three bisphosphonates: alendronate (BINOSTO, FOSAMAX), ibandronate (BONIVA) and risedronate (ACTONEL, ATELVIA). All three are available as pills, and one, ibandronate, also is available by injection. We have designated the bisphosphonate zoledronic acid (RECLAST) as Do Not Use for osteoporosis treatment because it causes kidney damage and stays in the bones for an exceptionally long period, potentially making side effects harder to treat.[14]

All other drugs approved for osteoporosis have more serious risks that outweigh any evidence of benefits and should not be used to treat osteoporosis. We list these drugs, including calcitonin (FORTICAL, MIACALCIN), teriparatide (FORTEO) and denosumab (PROLIA), as Do Not Use.

FDA-Approved Drugs for Osteoporosis[15]

Bisphosphonates work by slowing down the process by which bones are broken down, increasing bone density over time.[16] Multiple high-quality clinical trials have shown that bisphosphonates are effective in preventing hip fractures in women who are at high risk and already have had a fracture that a doctor determined was likely related to osteoporosis.

But even for these very high-risk women, the benefit is not huge. For example, in studies of alendronate and risedronate, for every 100 high-risk women who take bisphosphonates for three years, about one hip fracture will be prevented.[17],[18]

However, for women with high fracture risk who have not yet had a fracture, the evidence is less clear. Bisphosphonates do appear to prevent fractures in this group, but some of these fractures are tiny asymptomatic cracks to the spine that do not cause any noticeable discomfort or disability.[19],[20] No study yet has shown that drug treatment for this group of women can significantly reduce the risk of hip fracture.[21],[22],[23]

Bisphosphonates also have been linked with a number of troubling side effects, including throat and chest pain; severe bone, joint and muscle pain; bone and digestive disorders; inflammatory eye disease; and, in the case of ibandronate injection, severe allergic reaction.[24] There is some evidence that, more rarely, the drugs can cause bone loss in the jaw, atrial fibrillation (abnormal heart rhythm) and esophageal cancer.[25]

In addition, while bisphosphonates prevent the risk of bone fractures overall, they may contribute to unusual types of rare fracture in the thighbone.[26] This could be because the drugs interfere with the balance of the natural process by which bones are broken down and rebuilt, paradoxically making certain bones more brittle over time.[27]

How long should women use bisphosphonates?

Bisphosphonates remain in the body for long periods. They are incorporated into and stored in the bones and released slowly over time.[28] It is possible that long-term use may not be necessary or even helpful: Women can stop treatment after taking the drug for a few years, and the benefits will continue.

The FDA tested this possibility in 2011 by looking at results from clinical trials in which high-risk women who already had been treated with bisphosphonates for three or five years were randomly assigned to either continue treatment or switch to a placebo. The FDA found that there was no benefit to continuing treatment: The women who started taking a placebo at the three- or five-year mark had the same low fracture rate as women who continued treatment with bisphosphonates.[29] While other researchers have argued that some very high-risk women still may benefit from continuing treatment, the evidence for this is not strong.[30]

While taking bisphosphonates longer than five years does not appear to offer benefits, there is some evidence that it may increase the risk of side effects, including unusual thigh fractures[31],[32] and destruction of bone in the jaw.[33] For this reason, we recommend that women stop bisphosphonate treatment after three to five years.

Unfortunately, there are no good studies testing how long this break from drug treatment should last. For women with higher fracture risk, it may be reasonable to restart treatment with bisphosphonates after a break of a few years.[34] For patients whose fracture risk is low after treatment, starting drugs again will probably do more harm than good.

What You Can Do

Broken bones, particularly hip fractures, can have devastating consequences. All people — but particularly older women — should try to maintain strong bones by exercising regularly; eating a healthy, varied diet; and following the steps listed in this article to prevent falls that can lead to broken bones.

If you are a woman age 65 or older, ask your doctor to assess your fracture risk, looking at all of your risk factors and not just your bone density. If you are at high risk for fracture (meaning your risk of hip fracture is 3 percent or more over the next 10 years) and you already have experienced a broken bone, ask your doctor to prescribe alendronate, ibandronate or risedronate. Other drugs to treat osteoporosis should be avoided.

If you have high fracture risk but have never had an actual fracture, your doctor likely will discuss drug treatment. There is room for debate about whether drug treatment is necessary for all women in this group, because it has not been proven to reduce hip fractures. Women in this group should talk with their doctors about whether the side effects of treatment outweigh its benefits given their individual risk factors and personal preference.

Women who have a low or moderate risk of fracture and have not had a fracture in the past should not take drugs to prevent fractures. Drugs have not been shown to produce significant benefits in these women.

Use bisphosphonates for only three to five years. After this time period, you should talk with your doctor about either taking a break from treatment for several years or stopping treatment permanently, depending on your individual risk.

References

[1] Bernabei R, Martone A, Ortolani E, et al. Screening, diagnosis and treatment of osteoporosis: A brief review. Clinical Cases in Mineral and Bone Metabolism. 2014;11(3):201-207.

[2] Dilemmas in the management of osteoporosis. Drug and Therapeutics Bulletin. 2015;53:18-21.

[3] Willson T, Nelson SD, Newbold J, Nelson RE, LaFleur J. The clinical epidemiology of male osteoporosis: A review of the recent literature. Clin Epidemiol. 2015;7:65-76.

[4] U.S. Preventive Services Task Force. Screening for osteoporosis: U.S. preventive services task force recommendation. Ann Intern Med. 2011;154:356-364.

[5] Ibid.

[6] Wells GA, Cranney A, Peterson J, et al. Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database of Systematic Reviews. 2008;(1). Art. No.: CD004523.

[7] Centers for Disease Control and Prevention. Falls among older adults: an overview. Page last reviewed March 19, 2015. http://www.cdc.gov/HomeandRecreationalSafety/Falls/adultfalls.html. Accessed March 23, 2015.

[8] Dilemmas in the management of osteoporosis. Drug and Therapeutics Bulletin. 2015;53:18-21.

[9] World Health Organization. FRAX WHO fracture risk assessment tool. FRAX Tool. http://www.shef.ac.uk/FRAX/tool.aspx?country=9. Accessed March 19, 2015.

[10] Bernabei R, Martone A, Ortolani E, et al. Screening, diagnosis and treatment of osteoporosis: A brief review. Clinical Cases in Mineral and Bone Metabolism. 2014;11(3):201-207.

[11] National Osteoporosis Foundation. 2013 clinician's guide to prevention and treatment of osteoporosis. http://nof.org/files/nof/public/content/file/917/upload/481.pdf. Accessed March 23, 2015.

[12] World Health Organization. FRAX WHO fracture risk assessment tool. FRAX Tool. http://www.shef.ac.uk/FRAX/. Accessed March 19, 2015.

[13] Ibid.

[14] National Library of Medicine. DailyMed drug label: Reclast. Updated 01/15. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3c79ff9c-a6f4-405d-b19c-7e473a61dedc. Accessed March 23, 2015.

[15] National Osteoporosis Foundation. Clinician’s guide to prevention and treatment of osteoporosis. target="blank">http://nof.org/files/nof/public/content/file/2791/upload/919.pdf. (p.31) Accessed February 23, 2015.

[16] Food and Drug Administration. Background document for meeting of Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee. September 9, 2011. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM270958.pdf. Accessed February 25, 2015.

[17] Wells GA, Cranney A, Peterson J, et al. Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database of Systematic Reviews. 2008;(1). Art. No.: CD004523.

[18] Fosamax drug label. http://www.merck.com/product/usa/pi_circulars/f/fosamax/fosamax_pi.pdf. (p.16) Accessed February 23, 2015.

[19] Wells GA, Cranney A, Peterson J, et al. Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database of Systematic Reviews. 2008;(1). Art. No.: CD004523.

[20] Wells GA, Cranney A, Peterson J, Boucher M, Shea B, Welch V, Coyle D, Tugwell P. Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database of Systematic Reviews. 2008;(1). Art. No.: CD001155.

[21] Wells GA, Cranney A, Peterson J, et al. Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database of Systematic Reviews. 2008;(1). Art. No.: CD004523.

[22] Wells GA, Cranney A, Peterson J, Boucher M, Shea B, Welch V, Coyle D, Tugwell P. Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database of Systematic Reviews. 2008;(1). Art. No.: CD001155.

[23] Inderjeeth CA, Glendenning P, Ratnagobal S, Inderjeeth DC, Ondhia C, Long-term efficacy, safety, and patient acceptability of ibandronate in the treatment of postmenopausal osteoporosis. Int J Womens Health. 2015;7:7–17.

[24] National Library of Medicine. DailyMed drug label: Boniva. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5500be0f-8b29-450c-9857-755029965157. Accessed February 25, 2015.

[25] Food and Drug Administration. Background document for meeting of Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee. September 9, 2011. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM270958.pdf. Accessed February 25, 2015.

[26] Food and Drug Administration. Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa) information. http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm101551.htm.

[27] Long-term use of bisphosphonates for osteoporosis. Worst Pills, Best Pills News. January 2009. /newsletters/view/624. Accessed February 24, 2015.

[28] Brown JP, Morin S, Leslie W, et al. Bisphosphonates for treatment of osteoporosis: Expected harms, benefits, potential harms, and drug holidays. Can Fam Physician. 2014;60:324-333.

[29] Food and Drug Administration. Background document for meeting of Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee. September 9, 2011. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM270958.pdf. Accessed February 25, 2015.

[30] Black DM, Bauer DC, Schwartz AV, Cummings SR, Rosen CJ. Continuing bisphosphonate treatment for osteoporosis — for whom and how long? NEJM. 2012;366:2051-2053.

[31] Dilemmas in the management of osteoporosis. Drug and Therapeutics Bulletin. 2015;53:18-21.

[32] Edwards BJ, Bunta AD, Lane J, et al. Bisphosphonates and nonhealing femoral fractures: Analysis of the FDA adverse event reporting system (FAERS) and international safety efforts. J Bone Joint Surg Am. 2013;95:297-307.

[33] Food and Drug Administration. Background document for meeting of Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee. September 9, 2011. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM270958.pdf. Accessed February 25, 2015.

[34] Ro C, Cooper O. Bisphosphonate drug holiday: Choosing appropriate candidates. Curr Osteoporos Rep. 2013;11(1):45-51.