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

NCT00120757

CompletedPhase 3

Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Conditions: Osteoporosis, HIV Infections

Interventions: Alendronate

Countries: France

Osteopenia and osteoporosis are being described more frequently in people with HIV infection. This study will test the efficacy of alendronate in comparison with a placebo after 2 years, in people with primary osteoporosis. People will receive the recommended adequate intake of calcium and vitamin D.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (3)

Bobigny, France
Paris, France
Paris, France