Alendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIV
McComsey GA, Kendall MA, Tebas P, Swindells S, Hogg E, Alston-Smith B, Suckow C, Gopalakrishnan G, Benson C, Wohl DA
AIDS (London, England) · 109 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institute of Allergy and Infectious Diseases
- Gobierno
- National Center for Research Resources
- Gobierno
- NIAID NIH HHS
- Gobierno
- NCRR NIH HHS
- Subvenciones
- National Institute of Allergy and Infectious Diseases (AI025879); National Institute of Allergy and Infectious Diseases (AI46386); National Institute of Allergy and Infectious Diseases (AI50410); National Institute of Allergy and Infectious Diseases (AI-27664); National Center for Research Resources (MO1 RR000-96); National Center for Research Resources (RR00046); National Institute of Allergy and Infectious Diseases (AI27665); National Institute of Allergy and Infectious Diseases (UO1 AI38855); National Institute of Allergy and Infectious Diseases (AI 27658); National Institute of Allergy and Infectious Diseases (5 UO1 AI027666); National Center for Research Resources (MO1 RR 00047); National Institute of Allergy and Infectious Diseases (AI-46339); National Institute of Allergy and Infectious Diseases (01AI046383); National Institute of Allergy and Infectious Diseases (AI25915-); National Institute of Allergy and Infectious Diseases (UOI-AI 032783-13); National Institute of Allergy and Infectious Diseases (AI-25903); National Institute of Allergy and Infectious Diseases (UO1 AI38558); National Institute of Allergy and Infectious Diseases (UO1AI32782); National Center for Research Resources (MO1-RR-000-44); National Institute of Allergy and Infectious Diseases (AI2-7670); National Institute of Allergy and Infectious Diseases (AI 25868); National Institute of Allergy and Infectious Diseases (5-P30-AI-045008-07); National Institute of Allergy and Infectious Diseases (UO1 AI025924)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2007-11-30 · AIDS · vol. 21 · número 18 · págs. 2473–2482
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 156 citas · más que el 99% de estudios similares · 12.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 28 trabajos
- Acceso
- De pago
- Áreas de investigación
- HIV-related health complications and treatments · Bone health and osteoporosis research · Bone health and treatments
- Palabras clave
- alendronate, HIV infection, bone mineral density, osteoporosis, bisphosphonates, calcium and vitamin D supplementation, antiretroviral therapy, lumbar spine, hip bone density, drug safety
- MeSH
- humans, hiv infections, osteoporosis, calcium, alendronate, collagen type i, vitamin d, peptides, absorptiometry, photon, treatment outcome, drug therapy, combination, risk factors, prospective studies, sex factors, bone density, female, male, bone density conservation agents, biomarkers
10 autores
- Grace A. McComsey🇺🇸 · autor de correspondenciaRainbow Babies & Children's Hospital; Case Western Reserve University
- Michelle A. Kendall🇺🇸Harvard University
- Pablo Tebas🇺🇸University of Pennsylvania
- Susan Swindells🇺🇸University of Nebraska Medical Center
- Evelyn Hogg🇺🇸Social and Scientific Systems (United States)
- Beverly Alston‐Smith🇺🇸National Institutes of Health; National Institute of Allergy and Infectious Diseases
- Carol Suckow🇺🇸Frontier Science & Technology Research Foundation, Inc.
- Geetha Gopalakrishnan🇺🇸Brown University
- Constance Ann Benson🇺🇸University of California San Diego
- David Alain Wohl🇺🇸University of North Carolina at Chapel Hill
Resumen
El texto original del estudio, en el idioma en que se publicó.
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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