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Osteoporosis is a major health threat for an estimated 44 million Americans, 55% of which are aged 50 and older. One of the most common treatment options for osteoporosis is bisphosphonates, a class of drugs proven to slow the destruction of bone. Based on the treatment selected, medication is usually taken once daily, weekly, or monthly. The frequency of typical medication regimens, however, may contribute to poor adherence in long-term therapy. This can compromise the efficacy of treatments designed to reduce the risk of fracture. Other drawbacks include the potential side effects of oral bisphosphonates, including stomach or esophageal irritation, myalgia, or athralgia. In addition, when certain foods and liquids are taken with an oral bisphosphonate, the ability of these drugs to be absorbed can decrease considerably, rendering the efficacy of treatment to become poorer.

Addressing Adherence & Absorption Concerns

Zoledronic acid, a bisphosphonate, was recently approved by the FDA for the treatment of post-menopausal osteoporosis and Paget’s disease. According to results of a 3-year trial published in the May 3, 2007 New England Journal of Medicine, once-yearly infusions of zoledronic acid led to a sustained reduction in bone turnover. It also increased bone mineral density and reduced the risk for fractures in areas of the body typically affected by osteoporosis; the risk of hip fracture was shown to decrease by 41%. The agent also correlated with reduced risk for non-vertebral fractures, clinical fractures, and clinical vertebral fractures by 25%, 33%, and 77%, respectively. It is important to note that only 20% of patients evaluated were also administered a traditional medication for the treatment of osteoporosis. As a result, findings suggest that zoledronic acid is a more efficacious option and does not need to be combined with other medications for optimal use.

In addition, zoledronic acid is the only medication administered to patients in the exact dosage amount it was studied. This is not the case for all other medications approved for osteoporosis. The once-yearly administration eliminates many drug adherence and absorption issues associated with traditional treatment options.

Tackling Mortality Issues

Zoledronic acid also appears to significantly reduce mortality rates in patients with osteoporotic fractures. In a recurrent fracture trial published in the November 7, 2007 issue of the New England Journal of Medicine, my colleagues and I reviewed patients with existing hip fractures who were administered zoledronic acid. Patients receiving the agent had a significant reduction in fracture risk and also exhibited a 28% decrease in mortality. These statistics on mortality are significant because patients with osteoporosis who fracture their hip have an increased probability of dying within the first year after such an event. Moreover, about half of all patients will not return to their previous functional status before the incident. Studies have shown that about one-third of patients will not live through the first year (due to pneumonia while hospitalized, blood clots, etc); and another third will be forced into nursing homes.

Healthcare providers seldom treat osteoporosis with the same urgency as other medical conditions, but the presence of fractures and/or the tendency for fractures in this patient population should make the condition a higher priority. Efforts are needed to treat osteoporosis effectively in order to reduce the potentially detrimental consequences, and, fortunately, new therapies are continuing to emerge.

Dr. Recknor has indicated to Physician’s Weekly that he has received consulting fees from Procter & Gamble, Roche, and Eli Lilly. He also has received lecture fees from Procter & Gamble, Eli Lilly, Roche, GlaxoSmithKline, Merck, and Aventis. He has received grant support from Procter & Gamble.