Osteopenia and osteoporosis are frequent complications of HIV infection and/or its treatment. Alendronate is the only bisphosphonate approved for the treatment of osteoporosis in men and women. We conducted a 48-week prospective, randomized, open-label study to evaluate the effects of alendronate, vitamin D, and calcium supplementation on bone mineral density (BMD) in patients with HIV infection.
Thirty-one HIV-infected subjects with lumbar spine BMD t-scores less than −1.0 on antiretroviral therapy for a minimum of 6 months were randomized to receive (n = 15) or not to receive (n = 16) 70 mg of alendronate weekly for 48 weeks. All subjects received calcium (1000 mg daily as calcium carbonate) and vitamin D supplementation (400 IU daily). The study was powered to detect 3% changes in BMD in the lumbar spine within arms at 48 weeks.
Thirty-one patients were enrolled; most were male, with an average length of HIV infection of 8 years. Eighty-four percent had an HIV RNA load below 400 copies/mL, with a current median CD4+ T-cell count of 561 cells/mm3 (median nadir CD4 cell count of 167 cells/mm3). At baseline, the median t-score in the lumbar spine was −1.52 and the median t-score in the hip was −1.02. Alendronate in combination with vitamin D and calcium increased lumbar spine BMD by 5.2% (95% confidence interval [CI]: 1.3-6.4) at 48 weeks compared with an increase of 1.3% (95% CI: −2.4 to 4.0) in subjects receiving vitamin D and calcium alone. One subject discontinued treatment in each arm. There were no serious adverse events.
Alendronate, vitamin D, and calcium are safe and potentially useful in the treatment of osteopenia/osteoporosis associated with HIV infection.
From the *Washington University School of Medicine, Division of Infectious Diseases, St. Louis, MO; †Washington University School of Medicine, Division of Endocrinology, St. Louis, MO; and ‡University of Pennsylvania, School of Medicine, Division of Infectious Diseases, Philadelphia, PA.
Received for publication May 13, 2004; accepted September 2, 2004.
Supported in part by AI25903, AI032783, and AI01612 and a grant from the Campbell Foundation. Dr. Tebas is a recipient of the Glaxo SmithKline Development Partners Junior Faculty.
Reprints: Pablos Tebas, University of Pennsylvania, Division of Infectious Diseases, 502 Johnson Pavilion, 3610 Hamilton Walk, Philadelphia, PA 19104-6073 (e-mail: Pablo.Tebas@uphs.upenn.edu).