A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Once-Weekly Alendronate in HIV-Infected Subjects With Decreased Bone Mineral Density Receiving Calcium and Vitamin D

Decreased bone mineral density (BMD) has been identified in up to 50% of HIV infected men, with severe osteoporosis in up to 21% of these men. The mechanisms underlying these bone abnormalities remain unclear. Bisphosphonates are potent bone resorption inhibitors and have been shown to be effective in treating osteoporosis. While several bisphosphonates are approved for the treatment of osteoporosis in women, alendronate is the only bisphosphonate approved for treatment in men. This study hypothesizes that alendronate will be able to reverse decreased BMD secondary to inhibition of bone resorption in HIV infected patients treated with potent antiretroviral therapy, and that these patients will be able to tolerate alendronate without any significant toxicities. The study will also examine the efficacy of once-weekly alendronate with daily calcium and vitamin D in both men and women with HIV.

Patients will participate in this study for 48 weeks. Patients will be randomly assigned to receive either alendronate or placebo. All patients will receive calcium and vitamin D. Dual energy x-ray absorptiometry (DEXA) scans will be used to evaluate bone density at each visit. After study entry, patients will have visits at Weeks 2, 12, 24, 36, and 48. During these visits, blood will be drawn and a pregnancy test may be performed. Patients must fast for at least 8 hours prior to the entry visit and for the visits at Weeks 2, 12, 24, and 48.