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Ensayo controlado aleatorizado2006Financiación no declarada

Calcium plus vitamin D supplementation and the risk of fractures

Jackson RD, LaCroix AZ, Gass M, Wallace RB, Robbins J, Lewis CE, Bassford T, Beresford SA, Black HR, Blanchette P, Bonds DE, Brunner RL, Brzyski RG, Caan B, Cauley JA, Chlebowski RT, Cummings SR, Granek I, Hays J, Heiss G, Hendrix SL, Howard BV, Hsia J, Hubbell FA, Johnson KC, Judd H, Kotchen JM, Kuller LH, Langer RD, Lasser NL, Limacher MC, Ludlam S, Manson JE, Margolis KL, McGowan J, Ockene JK, O'Sullivan MJ, Phillips L, Prentice RL, Sarto GE, Stefanick ML, Van Horn L, Wactawski-Wende J, Whitlock E, Anderson GL, Assaf AR, Barad D, Women's Health Initiative Investigators

The New England journal of medicine · 1,111 citas

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Financiación no declarada

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Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Eventos clínicos como enfermedad o muerte

Quién lo pagó

Financiación
Financiación no declarada

Publicación

Publicado
2006-02-15 · N Engl J Med · vol. 354 · número 7 · págs. 669–683
Editorial
Massachusetts Medical Society
Citado
1,884 citas · más que el 100% de estudios similares · 158.9× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
88 trabajos
Acceso
Lectura gratuita
Áreas de investigación
Bone health and osteoporosis research · Vitamin D Research Studies · Menopause: Health Impacts and Treatments
Palabras clave
calcium supplementation, vitamin D supplementation, hip fracture, spinal fractures, postmenopausal women, bone mineral density, kidney stones, fracture prevention, Women's Health Initiative
MeSH
humans, kidney calculi, spinal fractures, hip fractures, calcium carbonate, calcium, vitamin d, drug combinations, estrogen replacement therapy, proportional hazards models, risk, follow-up studies, double-blind method, patient compliance, postmenopause, bone density, drug interactions, aged, middle aged, female, fractures, bone

47 autores

  • Rebecca D. Jackson🇺🇸The Ohio State University
  • Andrea Z. LaCroix🇺🇸The Ohio State University
  • Margery L S Gass🇺🇸The Ohio State University
  • Robert B. Wallace🇺🇸The Ohio State University
  • John A. Robbins🇺🇸The Ohio State University
  • Cora Elizabeth Lewis🇺🇸The Ohio State University
  • Tamsen L. Bassford🇺🇸The Ohio State University
  • Shirley A.A. Beresford🇺🇸The Ohio State University
  • Henry Richard Black🇺🇸The Ohio State University
  • Patricia Lanoie Blanchette🇺🇸The Ohio State University
  • Denise E. Bonds🇺🇸The Ohio State University
  • Robert L. Brunner🇺🇸The Ohio State University
  • Robert G. Brzyski🇺🇸The Ohio State University
  • Bette Jane Caan🇺🇸The Ohio State University
  • Jane A. Cauley🇺🇸The Ohio State University
  • Rowan T. Chlebowski🇺🇸The Ohio State University
  • Steven Ron Cummings🇺🇸The Ohio State University
  • Iris A. Granek🇺🇸The Ohio State University
  • Jennifer Hays-Grudo🇺🇸The Ohio State University
  • Gerardo M HEISS🇺🇸The Ohio State University
  • Susan L. Hendrix🇺🇸The Ohio State University
  • Barbara V. Howard🇺🇸The Ohio State University
  • Judith A. Hsia🇺🇸The Ohio State University
  • F. Allan Hubbell🇺🇸The Ohio State University
  • Karen Johnson🇺🇸The Ohio State University
  • Howard Judd🇺🇸The Ohio State University
  • Jane Morley Kotchen🇺🇸The Ohio State University
  • Lewis H. Kuller🇺🇸The Ohio State University
  • Robert D. Langer🇺🇸The Ohio State University
  • Norman L. Lasser🇺🇸The Ohio State University
  • Marian C. Limacher🇺🇸The Ohio State University
  • Shari Ludlam🇺🇸The Ohio State University
  • JoAnn E. Manson🇺🇸The Ohio State University
  • Karen L. Margolis🇺🇸The Ohio State University
  • Joan McGowan🇺🇸The Ohio State University
  • Judith K. Ockene🇺🇸The Ohio State University
  • Mary Jo O’Sullivan🇺🇸The Ohio State University
  • Lawrence S. Phillips🇺🇸The Ohio State University
  • Ross L. Prentice🇺🇸The Ohio State University
  • Gloria E. Sarto🇺🇸The Ohio State University
  • Marcia L. Stefanick🇺🇸The Ohio State University
  • Linda Van Horn🇺🇸The Ohio State University
  • Jean Wactawski‐Wende🇺🇸The Ohio State University
  • Evelyn P Whitlock🇺🇸The Ohio State University
  • Garnet L. Anderson🇺🇸The Ohio State University
  • Annlouise R. Assaf🇺🇸The Ohio State University
  • David H. Barad🇺🇸The Ohio State University

Resumen

El texto original del estudio, en el idioma en que se publicó.

Background

The efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal.

Methods

We recruited 36,282 postmenopausal women, 50 to 79 years of age, who were already enrolled in a Women's Health Initiative (WHI) clinical trial. We randomly assigned participants to receive 1000 mg of elemental [corrected] calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo. Fractures were ascertained for an average follow-up period of 7.0 years. Bone density was measured at three WHI centers.

Results

Hip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group (P<0.01). Intention-to-treat analysis indicated that participants receiving calcium plus vitamin D supplementation had a hazard ratio of 0.88 for hip fracture (95 percent confidence interval, 0.72 to 1.08), 0.90 for clinical spine fracture (0.74 to 1.10), and 0.96 for total fractures (0.91 to 1.02). The risk of renal calculi increased with calcium plus vitamin D (hazard ratio, 1.17; 95 percent confidence interval, 1.02 to 1.34). Censoring data from women when they ceased to adhere to the study medication reduced the hazard ratio for hip fracture to 0.71 (95 percent confidence interval, 0.52 to 0.97). Effects did not vary significantly according to prerandomization serum vitamin D levels.

Conclusions

Among healthy postmenopausal women, calcium with vitamin D supplementation resulted in a small but significant improvement in hip bone density, did not significantly reduce hip fracture, and increased the risk of kidney stones. (ClinicalTrials.gov number, NCT00000611.).

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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