Status:
COMPLETED
Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
Osteoporosis
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 wit...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2008
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00120757
Start Date
October 1 2004
End Date
November 1 2008
Last Update
December 22 2011
Active Locations (3)
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1
Service de Medecine Interne hopital Avicenne
Bobigny, France, 93009 cedex
2
Service de Rhumatologie hopital Pitie-Salpetriere
Paris, France, 75013
3
Hôpital Necker service des Maladies Infectieuses
Paris, France, 75015