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

Phase 3

Completed

• Conditions: Osteoporosis; HIV Infections

• Registration Number: NCT00120757
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

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 with primary osteoporosis. People will receive the recommended adequate intake of calcium and vitamin D.

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 cohort of HIV patients from the screening phase

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-07-11
• Study First Submitted QC: 2005-07-18
• Study First Posted: 2005-07-19
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Service de Medecine Interne hopital Avicenne; 🇫🇷 Bobigny, France

Service de Rhumatologie hopital Pitie-Salpetriere; 🇫🇷 Paris, France

Hôpital Necker service des Maladies Infectieuses; 🇫🇷 Paris, France