Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)

Inclusion Criteria: * Non-pregnant * Non menopausal women * Total femur BMD below -2.5 SD (T score) or lumbar spine BMD below -2.5 SD (T score) or BMD below -1 associated with a vertebral osteoporotic fracture (diminution of vertebral height over 20%) * HIV infection known for at least 5 years * CD4 cell count over 50/mm3 * Karnofsky score over or equal to 70 * Written informed consent. Exclusion Criteria: * Osteoporosis resulting from a cause other than HIV: vitamin D deficiency (in that case, after receiving high-dose calcium and vitamin D for 1 month, patients will be randomized without a new screening), renal failure, heart failure (NHYA class III or IV), treatment with glucocorticoid at a dose over or equal to 0.5mg/kg/d for 15 days or more at time of inclusion or during the previous 6 months; thyroid or other endocrine disease if untreated for more than 6 months; hypercalciuria * Testosterone below normal if treatment is hormonal * BMI below or equal to 18 * Severe lung failure * Chronic alcohol intoxication * Ongoing opportunistic infection * Gastric ulcer of disease interfering with oesophageal motility in the previous 3 months * History of treatment for osteoporosis * History of malignancy in the previous 5 years (except skin cancer and Kaposi) * Cytotoxic chemotherapy or cytokine therapy * Liver cirrhosis * Breast feeding