Official Title: “Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2008

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

Intervention(s) in this Clinical Trial

• Drug: Alendronate

Primary Measures

• Percentage of variation of lumbar BMD on DEXA scan at month 24 versus month 0 for patients included with lumbar osteoporosis (femoral for those included with only femoral osteoporosis)

Secondary Measures

• Percentage of variation of femoral T-score between M0 and M24
• Percentages of variation of lumbar and femoral T score between M0 and M12
• Evolution of bone metabolism markers
• Occurrence of fractures
• Tolerance of alendronate
• Measure of the prevalence of osteopenia and osteoporosis in HIV-infected men and women
• Description of the evolution of osteoporosis in HIV-infected men and women receiving calcium and vitamin D to define risk factors for osteoporosis in HIV-infected persons

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

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

Overall Clinical Trial Officials and Contacts

Sylvie Rozenberg, MD Principal Investigator Hopital Pitie-Salpetriere Paris service de Rhumatologie  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00120757

Study ID Number: 2004-002002-30

ClinicalTrials.gov Identifier: NCT00120757

Health Authority: France: Afssaps - French Health Products Safety Agency