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

NCT ID: NCT00120757

Last Updated: 2011-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2008-11-30

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

Conditions

Osteoporosis; HIV Infections

Keywords

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Alendronate

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Rozenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Pitie-Salpetriere Paris service de Rhumatologie

Dominique Costagliola

Role: STUDY_CHAIR

Inserm U720

Locations

Service de Medecine Interne hopital Avicenne

Bobigny, , France

Service de Rhumatologie hopital Pitie-Salpetriere

Paris, , France

Hôpital Necker service des Maladies Infectieuses

Paris, , France

Countries

France

References

Rozenberg S, Lanoy E, Bentata M, Viard JP, Valantin MA, Missy P, Darasteanu I, Roux C, Kolta S, Costagliola D; ANRS 120 Fosivir Study Group. Effect of alendronate on HIV-associated osteoporosis: a randomized, double-blind, placebo-controlled, 96-week trial (ANRS 120). AIDS Res Hum Retroviruses. 2012 Sep;28(9):972-80. doi: 10.1089/AID.2011.0224. Epub 2012 Mar 23.

Reference Type: DERIVED

PMID: 22353022 (View on PubMed)

Other Identifiers

ANRS120 Fosivir

Identifier Type: -

Identifier Source: secondary_id

2004-002002-30

Identifier Type: -

Identifier Source: org_study_id