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

TitleAlendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIV.
Publication TypeJournal Article
Year of Publication2007
AuthorsMcComsey GA, Kendall MA, Tebas P, Swindells S, Hogg E, Alston-Smith B, Suckow C, Gopalakrishnan G, Benson C, Wohl DA
JournalAIDS
Volume21
Issue18
Pagination2473-82
Date Published2007 Nov 30
ISSN1473-5571
KeywordsAbsorptiometry, 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
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.

DOI10.1097/QAD.0b013e3282ef961d
Alternate JournalAIDS
PubMed ID18025884
Grant List01AI046383 / AI / NIAID NIH HHS / United States
5 UO1 AI027666 / AI / NIAID NIH HHS / United States
5-P30-AI-045008-07 / AI / NIAID NIH HHS / United States
AI -27665 / AI / NIAID NIH HHS / United States
AI 25915 / AI / NIAID NIH HHS / United States
AI 27664 / AI / NIAID NIH HHS / United States
AI025879 / AI / NIAID NIH HHS / United States
AI25868 / AI / NIAID NIH HHS / United States
AI25903 / AI / NIAID NIH HHS / United States
AI27658 / AI / NIAID NIH HHS / United States
AI27670 / AI / NIAID NIH HHS / United States
AI46339 / AI / NIAID NIH HHS / United States
AI46386 / AI / NIAID NIH HHS / United States
AI50410 / AI / NIAID NIH HHS / United States
MO1 RR00044 / RR / NCRR NIH HHS / United States
MO1 RR00047 / RR / NCRR NIH HHS / United States
MO1-RR00096 / RR / NCRR NIH HHS / United States
RR00046 / RR / NCRR NIH HHS / United States
UO1 AI025924 / AI / NIAID NIH HHS / United States
UO1 AI38558 / AI / NIAID NIH HHS / United States
UO1 AI38855 / AI / NIAID NIH HHS / United States
UO1AI32782 / AI / NIAID NIH HHS / United States
UOI-AI 032783-13 / AI / NIAID NIH HHS / United States