Alendronate, vitamin D, and calcium for the treatment of osteopenia/osteoporosis associated with HIV infection
Mondy K, Powderly WG, Claxton SA, Yarasheski KH, Royal M, Stoneman JS, Hoffmann ME, Tebas P
Journal of acquired immune deficiency syndromes (1999) · 91 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 Institute of Diabetes and Digestive and Kidney Diseases
- Gobierno
- NIAID NIH HHS
- Gobierno
- NIDDK NIH HHS
- Subvenciones
- National Institute of Allergy and Infectious Diseases (AI 032783); National Institute of Allergy and Infectious Diseases (AI 01612); National Institute of Diabetes and Digestive and Kidney Diseases (R01 DK054163); National Institute of Diabetes and Digestive and Kidney Diseases (R01 DK059531); National Institute of Allergy and Infectious Diseases (AI-25903); National Institute of Diabetes and Digestive and Kidney Diseases (R01DK049393)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2005-03-01 · J Acquir Immune Defic Syndr · vol. 38 · número 4 · págs. 426–431
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 152 citas · más que el 99% de estudios similares · 12.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 16 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, vitamin D supplementation, calcium supplementation, HIV-associated osteoporosis, bone mineral density, bisphosphonates, lumbar spine, antiretroviral therapy, CD4 count
- MeSH
- lumbar vertebrae, humans, hiv infections, bone diseases, metabolic, osteoporosis, spinal diseases, calcium, alendronate, vitamin d, absorptiometry, photon, medical history taking, monitoring, physiologic, cd4 lymphocyte count, bone density, time factors, adult, middle aged, female, male
8 autores
- Kristin E. Mondy🇺🇸 · autor de correspondenciaWashington University in St. Louis
- William G. Powderly🇺🇸 · autor de correspondenciaWashington University in St. Louis
- Sherry Claxton🇺🇸 · autor de correspondenciaWashington University in St. Louis
- Kevin E. Yarasheski🇺🇸Washington University in St. Louis
- Michael Royal🇺🇸 · autor de correspondenciaWashington University in St. Louis
- John S Stoneman🇺🇸 · autor de correspondenciaWashington University in St. Louis
- Mary E Hoffmann🇺🇸 · autor de correspondenciaWashington University in St. Louis
- Pablo Tebas🇺🇸University of Pennsylvania
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Osteopenia and osteoporosis are frequent complications of HIV infection and/or its treatment. Alendronate is the only bisphosphonate approved for the treatment of osteoporosis in men and women. We conducted a 48-week prospective, randomized, open-label study to evaluate the effects of alendronate, vitamin D, and calcium supplementation on bone mineral density (BMD) in patients with HIV infection.
Methods
Thirty-one HIV-infected subjects with lumbar spine BMD t-scores less than -1.0 on antiretroviral therapy for a minimum of 6 months were randomized to receive (n = 15) or not to receive (n = 16) 70 mg of alendronate weekly for 48 weeks. All subjects received calcium (1000 mg daily as calcium carbonate) and vitamin D supplementation (400 IU daily). The study was powered to detect 3% changes in BMD in the lumbar spine within arms at 48 weeks.
Results
Thirty-one patients were enrolled; most were male, with an average length of HIV infection of 8 years. Eighty-four percent had an HIV RNA load below 400 copies/mL, with a current median CD4+ T-cell count of 561 cells/mm3 (median nadir CD4 cell count of 167 cells/mm). At baseline, the median t-score in the lumbar spine was -1.52 and the median t-score in the hip was -1.02. Alendronate in combination with vitamin D and calcium increased lumbar spine BMD by 5.2% (95% confidence interval [CI]: 1.3-6.4) at 48 weeks compared with an increase of 1.3% (95% CI: -2.4 to 4.0) in subjects receiving vitamin D and calcium alone. One subject discontinued treatment in each arm. There were no serious adverse events.
Conclusions
Alendronate, vitamin D, and calcium are safe and potentially useful in the treatment of osteopenia/osteoporosis associated with HIV infection.
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