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