A double-blinded, randomized controlled trial of zoledronate therapy for HIV-associated osteopenia and osteoporosis

Abstract

Objective: To evaluate the efficacy of a single dose of intravenous zoledronate for the treatment of HIV-associated osteopenia and osteoporosis. Design: A double-blinded, randomized, placebo-controlled, 12-month trial of 5 mg intravenous zoledronate dose to treat 30 HIV-infected men and women with osteopenia and osteoporosis. Methods: Following zoledronate or placebo infusions, participants were followed for 12 months on daily calcium and vitamin D supplements. Lumbar spine and hip bone density was assessed at baseline, 6 and 12 months. Biomarkers of bone metabolism were measured at baseline, 2 weeks, 3, 6, 9, and 12 months. Student's t-test and repeated measure analyses were used to evaluate bone density and bone marker changes over time. Results: In the 30 HIV-infected individuals [men (27) and women (3)] in the trial, median T-scores at entry were −1.7 for the lumbar spine and −1.4 for the hip. Median CD4 cell count was 461 cells/μl, 93% had HIV-RNA viral loads less than 400 copies/ml, and 97% were taking antiretroviral medications. Bone density measured either absolutely or as sex-adjusted T-scores significantly improved in zoledronate recipients as compared with minimal changes in those receiving placebo. Bone resorption markers significantly decreased over the study period in the zoledronate recipients as compared with placebo controls. No acute infusion reactions were detected, but one patient developed uveitis, a recognized complication of zoledronate, which responded to therapy. Conclusion: In this small study, annual zoledronate appears to be a well tolerated and effective therapy for HIV-associated bone loss.