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Effect of alendronate on HIV-associated osteoporosis: a randomized, double-blind, placebo-controlled, 96-week trial (ANRS 120).

Abstract

Low bone mineral density (BMD) is common in HIV-infected patients. Bisphosphonates such as alendronate potently inhibit bone resorption and are effective against osteoporosis. The aim of the ANRS 120 Fosivir trial was to evaluate the effect of alendronate on low BMD in HIV-infected patients. HIV-1-infected adults with a t-score≤-2.5 at the lumbar spine and/or total hip, as assessed by dual x-ray absorptiometry, and no other known risk factors for low BMD, were randomized to receive either extended-release alendronate 70 mg weekly or placebo for 96 weeks, with stratification for gender. All the patients also received daily calcium carbonate (500 mg) and vitamin D (400 U). The primary endpoint for efficacy was the percentage change in BMD at the site with a t-score≤-2.5. Forty-four antiretroviral-treated patients (42 men, 2 women) were enrolled. The median age was 45 years, the median CD4 cell count was 422/mm(3), and viral load was <400 copies/ml in 84% of patients. Baseline characteristics were well balanced between the alendronate (n=20) and placebo (n=24) groups. At baseline, 15 patients (75%) in the alendronate group and 17 patients (71%) in the placebo group had a t-score≤-2.5 at the lumbar spine. In the main analysis, 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 at week 96 [mean difference, 6.1% (95% CI 2.8 to 9.3); p=0.0003]. Alendronate 70 mg weekly for 96 weeks improves BMD in HIV-1-infected patients on antiretroviral therapy.

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  • Authors+Show Affiliations

    ,

    AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Service de Rhumatologie, Paris, France. sylvie.rozenberg@psl.aphp.fr

    , , , , , , , , ,

    Source

    AIDS research and human retroviruses 28:9 2012 Sep pg 972-80

    MeSH

    Absorptiometry, Photon
    Acquired Immunodeficiency Syndrome
    Adult
    Alendronate
    Anti-HIV Agents
    Bone Density
    Bone Density Conservation Agents
    CD4 Lymphocyte Count
    Double-Blind Method
    Female
    France
    Hip
    Humans
    Lumbar Vertebrae
    Male
    Middle Aged
    Osteoporosis
    Treatment Outcome
    Viral Load

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    22353022

    Citation

    Rozenberg, Sylvie, et al. "Effect of Alendronate On HIV-associated Osteoporosis: a Randomized, Double-blind, Placebo-controlled, 96-week Trial (ANRS 120)." AIDS Research and Human Retroviruses, vol. 28, no. 9, 2012, pp. 972-80.
    Rozenberg S, Lanoy E, Bentata M, et al. Effect of alendronate on HIV-associated osteoporosis: a randomized, double-blind, placebo-controlled, 96-week trial (ANRS 120). AIDS Res Hum Retroviruses. 2012;28(9):972-80.
    Rozenberg, S., Lanoy, E., Bentata, M., Viard, J. P., Valantin, M. A., Missy, P., ... Costagliola, D. (2012). Effect of alendronate on HIV-associated osteoporosis: a randomized, double-blind, placebo-controlled, 96-week trial (ANRS 120). AIDS Research and Human Retroviruses, 28(9), pp. 972-80.
    Rozenberg S, et al. Effect of Alendronate On HIV-associated Osteoporosis: a Randomized, Double-blind, Placebo-controlled, 96-week Trial (ANRS 120). AIDS Res Hum Retroviruses. 2012;28(9):972-80. PubMed PMID: 22353022.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effect of alendronate on HIV-associated osteoporosis: a randomized, double-blind, placebo-controlled, 96-week trial (ANRS 120). AU - Rozenberg,Sylvie, AU - Lanoy,Emillie, AU - Bentata,Michelle, AU - Viard,Jean-Paul, AU - Valantin,Marc Antoine, AU - Missy,Pascale, AU - Darasteanu,Iuliana, AU - Roux,Christian, AU - Kolta,Sami, AU - Costagliola,Dominique, AU - ,, Y1 - 2012/03/23/ PY - 2012/2/23/entrez PY - 2012/2/23/pubmed PY - 2012/12/28/medline SP - 972 EP - 80 JF - AIDS research and human retroviruses JO - AIDS Res. Hum. Retroviruses VL - 28 IS - 9 N2 - Low bone mineral density (BMD) is common in HIV-infected patients. Bisphosphonates such as alendronate potently inhibit bone resorption and are effective against osteoporosis. The aim of the ANRS 120 Fosivir trial was to evaluate the effect of alendronate on low BMD in HIV-infected patients. HIV-1-infected adults with a t-score≤-2.5 at the lumbar spine and/or total hip, as assessed by dual x-ray absorptiometry, and no other known risk factors for low BMD, were randomized to receive either extended-release alendronate 70 mg weekly or placebo for 96 weeks, with stratification for gender. All the patients also received daily calcium carbonate (500 mg) and vitamin D (400 U). The primary endpoint for efficacy was the percentage change in BMD at the site with a t-score≤-2.5. Forty-four antiretroviral-treated patients (42 men, 2 women) were enrolled. The median age was 45 years, the median CD4 cell count was 422/mm(3), and viral load was <400 copies/ml in 84% of patients. Baseline characteristics were well balanced between the alendronate (n=20) and placebo (n=24) groups. At baseline, 15 patients (75%) in the alendronate group and 17 patients (71%) in the placebo group had a t-score≤-2.5 at the lumbar spine. In the main analysis, 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 at week 96 [mean difference, 6.1% (95% CI 2.8 to 9.3); p=0.0003]. Alendronate 70 mg weekly for 96 weeks improves BMD in HIV-1-infected patients on antiretroviral therapy. SN - 1931-8405 UR - https://www.unboundmedicine.com/medline/citation/22353022/Effect_of_alendronate_on_HIV_associated_osteoporosis:_a_randomized_double_blind_placebo_controlled_96_week_trial__ANRS_120__ L2 - https://www.liebertpub.com/doi/full/10.1089/AID.2011.0224?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -