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

NCT00120757 ↗

Phase 3 Completed 140 enrolled French National Agency for Research on AIDS and Viral Hepatitis

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2004-10
Primary completion: 2008-11
Completion: 2008-11

Outcome

Met primary endpoint

paper BMD at the site with a t-score≤-2.5 increased by 7.1% and 1.0%, respectively, in the alendronate (n=14) and placebo (n=20) groups PMID 22353022 ↗

paper mean difference, 6.1% (95% CI 2.8 to 9.3); p=0.0003 PMID 22353022 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alendronic Acid	Small molecule	70 mg	—