Overview

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

Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Treatments:
Alendronate
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