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Good news and bad news for osteoporosis patients taking Boniva

Robin Wulffson MD's picture
Boniva, Fosamax, bisphosphonates, osteoporosis, atypical fractures, generic

When one visits a pharmacy with a new prescription for treatment of a health problem, the price of the medication often triggers an attack of budget-bustitis. That sticker shock is mitigated when a generic version of a medication becomes available. That has now occurred for the osteoporosis medication Boniva (ibandronate).

On March 19, the Food and Drug Administration (FDA) announced that a generic version of Boniva has been approved. The announcement not only means that the cost of the medication will drop but also, because it is FDA approved, the generic version must meet the same high quality and strength as its brand-name equivalent. Ibandronate is a member of a class of medications called bisphosphonates. Apotex Inc. (Orchid Healthcare), and Mylan Pharmaceuticals Inc. are the two manufacturers that have received FDA approval to manufacture and market generic 150 milligram ibandronate tablets. Despite the good news regarding the generic version, there is a down-side to long-term use of bisphosphonates.

Boniva, which is taken once a month, promotes bone growth. Loss of bone mass results in the development of osteoporosis, which can lead to fractures of the hips, vertebrae, or wrists. An individual hobbling down the street, hunched over with a cane is most likely an osteoporosis sufferer. According to the FDA, 10 million people in the United States have osteoporosis, and another 34 million have osteopenia. Individuals with finer bones, such as Asians and Scandinavians, are at increased risk; African Americans are at decreased risk because they are endowed with heavier bones. All women, however, regardless of ethnicity, begin losing bone at the onset of menopause. This loss can be prevented with hormone replacement therapy (HRT). Although more women are affected by osteoporosis, men are also susceptible to osteoporosis as they age.

Boniva does have some side-effects. The most commonly observed adverse reactions are: back pain, indigestion (dyspepsia), pain in the arms and legs, diarrhea, headache, and muscle pain (myalgia). Many individuals on the medication endure these side effects, because they only have to suffer through them once a month. In addition to unpleasant side-effects, bisphosphonates have come under scrutiny because of reported cases of typical fractures of the femur (thigh bone) and jaw.

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Bone density screening soared after Fosamax, the first bisphosphonate, was approved at the end of 1995. For the first time, physicians had a specific treatment that had been shown to prevent fractures in people with osteoporosis. For many years doctors liberally prescribed the medication for women whose bone density was lower than normal but not in the danger zone; furthermore, they prescribed it indefinitely. However, recent reports of atypical fractures have caused physicians to reconsider long-term use. Last September, an advisory panel to the FDA has voted 17 to 6 to recommend that the labeling for bisphosphonates for the treatment of osteoporosis become more specific about how long the drugs should be used. Currently, many physicians generally recommend that most individuals on bisphosphonates take them for just five years at a time, followed by a drug holiday of undetermined length. The goal is to reduce the small but serious risk of atypical fractures.

Another bon-building medication holds promise and may replace bisphosphonates for osteoporosis treatment. Last November, the results from the first three years of a study of denosumab, a different type of bone-building agent, were presented. The material was presented at the American College of Rheumatology (ACR) 2011 Annual Meeting in Chicago. The study found that, in addition to strengthening bone, no atypical fractures occurred.

The trial was termed the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM). The study group was comprised of 7,868 women 60 to 90 years of age with decreased bone density who were randomly assigned to receive denosumab or a placebo. Approximately 70% of the original participants continued in the follow-up study. Of these, 2,343 continued to receive denosumab and 2,207 crossed over from placebo to denosumab. The women continue to receive denosumab, 60 mg every six months, and take supplemental calcium and vitamin D daily. They will be followed for a total of 10 years.

The researchers found that women in the long-term group continue to demonstrate bone mineral density (BMD gains): 5.1% improvement at the lumbar spine and 1.8% in the total hip, for cumulative gains of 15.2% at the lumbar spine and 7.5% total hip compared with baseline. Women in the crossover group demonstrated BMD gains similar to those seen in the original study: 9.4% in the lumbar spine and 4.8% in the total hip.

Reference: FDA