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Alendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIV.

Abstract

BACKGROUND

Decreased bone mineral density (BMD) is prevalent in HIV-infected patients. Bisphosphonates are currently the mainstay of treatment for postmenopausal and male osteoporosis in HIV-uninfected individuals; however, their efficacy and safety in HIV-infected patients remains unclear.

METHODS

In this prospective, randomized, placebo-controlled multicenter trial, we studied the effectiveness of calcium and vitamin D supplementation with or without alendronate in improving BMD in HIV-infected subjects receiving stable antiretroviral therapy. Subjects with secondary causes of osteoporosis were excluded. The study was powered to detect differences of 3.5% between arms and to detect a moderate sex effect in percentage change in lumbar spine BMD. All dual-energy X-ray absorptiometry scans were analysed centrally, blinded by arm.

RESULTS

The 82 subjects enrolled were 71% men, 77% white, with a baseline median age of 48 years, CD4 cell count of 469 cells/mul, and lumbar spine t-score of less than 2.1; 91% had HIV-RNA levels less than 400 copies/ml, and 99% were taking antiretroviral drugs. Compared with calcium/vitamin D alone, alendronate plus calcium/vitamin D resulted in significant improvements in BMD at the lumbar spine, total hip, and trochanter, but not at the femoral neck, compared with baseline. There were trends towards significant increases in BMD values in the calcium/vitamin D group at the lumbar spine, total hip, and femoral neck. There were no apparent sex differences in the responses to therapy. Alendronate was well tolerated, without significant adverse events.

CONCLUSION

Once-weekly alendronate is safe and effective in the treatment of decreased BMD in HIV-infected patients.

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  • Authors+Show Affiliations

    ,

    Rainbow Babies and Children's Hospital and Case Western Reserve University, Cleveland, Ohio, USA. gam9@case.edu

    , , , , , , , ,

    Source

    AIDS (London, England) 21:18 2007 Nov 30 pg 2473-82

    MeSH

    Absorptiometry, Photon
    Alendronate
    Biomarkers
    Bone Density
    Bone Density Conservation Agents
    Calcium
    Collagen Type I
    Drug Therapy, Combination
    Female
    HIV Infections
    Humans
    Male
    Osteoporosis
    Peptides
    Prospective Studies
    Risk Factors
    Sex Factors
    Treatment Outcome
    Vitamin D

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural

    Language

    eng

    PubMed ID

    18025884

    Citation

    McComsey, Grace A., et al. "Alendronate With Calcium and Vitamin D Supplementation Is Safe and Effective for the Treatment of Decreased Bone Mineral Density in HIV." AIDS (London, England), vol. 21, no. 18, 2007, pp. 2473-82.
    McComsey GA, Kendall MA, Tebas P, et al. Alendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIV. AIDS. 2007;21(18):2473-82.
    McComsey, G. A., Kendall, M. A., Tebas, P., Swindells, S., Hogg, E., Alston-Smith, B., ... Wohl, D. A. (2007). Alendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIV. AIDS (London, England), 21(18), pp. 2473-82.
    McComsey GA, et al. Alendronate With Calcium and Vitamin D Supplementation Is Safe and Effective for the Treatment of Decreased Bone Mineral Density in HIV. AIDS. 2007 Nov 30;21(18):2473-82. PubMed PMID: 18025884.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Alendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIV. AU - McComsey,Grace A, AU - Kendall,Michelle A, AU - Tebas,Pablo, AU - Swindells,Susan, AU - Hogg,Evelyn, AU - Alston-Smith,Beverly, AU - Suckow,Carol, AU - Gopalakrishnan,Geetha, AU - Benson,Constance, AU - Wohl,David A, PY - 2007/11/21/pubmed PY - 2008/1/17/medline PY - 2007/11/21/entrez SP - 2473 EP - 82 JF - AIDS (London, England) JO - AIDS VL - 21 IS - 18 N2 - BACKGROUND: Decreased bone mineral density (BMD) is prevalent in HIV-infected patients. Bisphosphonates are currently the mainstay of treatment for postmenopausal and male osteoporosis in HIV-uninfected individuals; however, their efficacy and safety in HIV-infected patients remains unclear. METHODS: In this prospective, randomized, placebo-controlled multicenter trial, we studied the effectiveness of calcium and vitamin D supplementation with or without alendronate in improving BMD in HIV-infected subjects receiving stable antiretroviral therapy. Subjects with secondary causes of osteoporosis were excluded. The study was powered to detect differences of 3.5% between arms and to detect a moderate sex effect in percentage change in lumbar spine BMD. All dual-energy X-ray absorptiometry scans were analysed centrally, blinded by arm. RESULTS: The 82 subjects enrolled were 71% men, 77% white, with a baseline median age of 48 years, CD4 cell count of 469 cells/mul, and lumbar spine t-score of less than 2.1; 91% had HIV-RNA levels less than 400 copies/ml, and 99% were taking antiretroviral drugs. Compared with calcium/vitamin D alone, alendronate plus calcium/vitamin D resulted in significant improvements in BMD at the lumbar spine, total hip, and trochanter, but not at the femoral neck, compared with baseline. There were trends towards significant increases in BMD values in the calcium/vitamin D group at the lumbar spine, total hip, and femoral neck. There were no apparent sex differences in the responses to therapy. Alendronate was well tolerated, without significant adverse events. CONCLUSION: Once-weekly alendronate is safe and effective in the treatment of decreased BMD in HIV-infected patients. SN - 1473-5571 UR - https://www.unboundmedicine.com/medline/citation/18025884/Alendronate_with_calcium_and_vitamin_D_supplementation_is_safe_and_effective_for_the_treatment_of_decreased_bone_mineral_density_in_HIV_ L2 - http://Insights.ovid.com/pubmed?pmid=18025884 DB - PRIME DP - Unbound Medicine ER -