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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Completed

Phase 3

Conditions

Osteoporosis

HIV Infections

Treatments

Drug: Alendronate

Study type

Interventional

Funder types

Other

Identifiers

NCT00120757

ANRS120 Fosivir

2004-002002-30

Details and patient eligibility

About

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.

Full description

The purposes of this trial are:

To study the efficacy of alendronate in HIV-associated osteoporosis
To measure the prevalence of osteoporosis in HIV patients and to detect risk factors in a large cohort of HIV patients from the screening phase

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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