HIV Infections Clinical Trial
Official title:
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
Alendronate is a drug that is used to treat osteoporosis. The purpose of this study is to examine whether alendronate in combination with calcium and vitamin D is safe and effective for treating bone loss in people with HIV.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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