Effect of calcium supplementation on fracture risk: a double-blind randomized controlled trial.

BACKGROUND The effect of supplementation with calcium alone on risk fractures in a healthy population is not clear. OBJECTIVE The objective was to determine whether 4 y of calcium supplementation would reduce the fracture risk during treatment and subsequent follow-up in a randomized placebo-controlled trial. DESIGN The participants were aged <80 y at study entry (mean age: 61 y), were generally healthy, and had a recent diagnosis of colorectal adenoma. A total of 930 participants (72% men; mean age: 61 y) were randomly assigned to receive 4 y of treatment with 3 g CaCO(3) (1200 mg elemental Ca) daily or placebo and were followed for a mean of 10.8 y. The primary outcomes of this analysis were all fractures and minimal trauma fractures (caused by a fall from standing height or lower while sitting, standing, or walking). RESULTS There were 46 fractures (15 from minimal trauma) in 464 participants in the calcium group and 54 (29 from minimal trauma) in 466 participants in the placebo group. The overall risk of fracture differed significantly between groups during the treatment phase [hazard ratio (HR): 0.28; 95% CI: 0.09, 0.85], but not during the subsequent posttreatment follow-up (HR: 1.10; 95% CI: 0.71, 1.69). Minimal trauma fractures were also less frequent in the calcium group during treatment (HR: 0; 95% CI: 0, 0.50). CONCLUSION Calcium supplementation reduced the risk of all fractures and of minimal trauma fractures among healthy individuals. The benefit appeared to dissipate after treatment was stopped. This trial was registered at clinicaltrials.gov as NCT00153816.

[1]  D. Kiel,et al.  Calcium intake and hip fracture risk in men and women: a meta-analysis of prospective cohort studies and randomized controlled trials. , 2007, The American journal of clinical nutrition.

[2]  R. Lindsay,et al.  Calcium and fracture risk. , 2007, The American journal of clinical nutrition.

[3]  G. Guyatt,et al.  Calcium supplementation on bone loss in postmenopausal women. , 2007, The Cochrane database of systematic reviews.

[4]  I. Reid,et al.  Randomized controlled trial of calcium in healthy older women. , 2006, The American journal of medicine.

[5]  Richard L Prince,et al.  Effects of calcium supplementation on clinical fracture and bone structure: results of a 5-year, double-blind, placebo-controlled trial in elderly women. , 2006, Archives of internal medicine.

[6]  J. Manson,et al.  Calcium plus vitamin D supplementation and the risk of fractures. , 2006, The New England journal of medicine.

[7]  G. Sigurdsson,et al.  Relationship between serum parathyroid hormone levels, vitamin D sufficiency, and calcium intake. , 2005, JAMA.

[8]  C. Cooper,et al.  Oral vitamin D3 and calcium for secondary prevention of low-trauma fractures in elderly people (Randomised Evaluation of Calcium Or vitamin D, RECORD): a randomised placebo-controlled trial , 2005, The Lancet.

[9]  David J Torgerson,et al.  Primary care Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D 3 ) for prevention of fractures in primary care , 2005 .

[10]  R. Lyons,et al.  The effect of socioeconomic deprivation on fracture incidence in the United Kingdom , 2004, Osteoporosis International.

[11]  A. Wolk,et al.  Dietary calcium and vitamin D intake in relation to osteoporotic fracture risk. , 2003, Bone.

[12]  Cecilia A. Hale,et al.  Calcium Absorption Varies within the Reference Range for Serum 25-Hydroxyvitamin D , 2003, Journal of the American College of Nutrition.

[13]  W. Willett,et al.  Calcium, vitamin D, milk consumption, and hip fractures: a prospective study among postmenopausal women. , 2003, The American journal of clinical nutrition.

[14]  G. Guyatt,et al.  Meta-analyses of therapies for postmenopausal osteoporosis. VII. Meta-analysis of calcium supplementation for the prevention of postmenopausal osteoporosis. , 2002, Endocrine reviews.

[15]  M. Schlichting,et al.  Combined Calcium and Vitamin D3 Supplementation in Elderly Women: Confirmation of Reversal of Secondary Hyperparathyroidism and Hip Fracture Risk: The Decalyos II Study , 2002, Osteoporosis International.

[16]  J. Pasco,et al.  Fracture rates lower in rural than urban communities: the Geelong Osteoporosis Study , 2002, Journal of epidemiology and community health.

[17]  Susan R. Johnson,et al.  Osteoporosis prevention, diagnosis, and therapy. , 2001, JAMA.

[18]  G. Beck,et al.  Calcium supplements for the prevention of colorectal adenomas. Calcium Polyp Prevention Study Group. , 1999, The New England journal of medicine.

[19]  W. O'Fallon,et al.  Long‐Term Effects of Calcium Supplementation on Serum Parathyroid Hormone Level, Bone Turnover, and Bone Loss in Elderly Women , 1998, Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research.

[20]  G E Dallal,et al.  Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. , 1997, The New England journal of medicine.

[21]  D. Spiegelman,et al.  Calcium intake and the incidence of forearm and hip fractures among men. , 1997, The Journal of nutrition.

[22]  S. Cummings,et al.  Calcium intake and fracture risk: results from the study of osteoporotic fractures. , 1997, American journal of epidemiology.

[23]  B. Specker,et al.  Evidence for an interaction between calcium intake and physical activity on changes in bone mineral density , 1996, Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research.

[24]  L. Bouter,et al.  Vitamin D Supplementation and Fracture Incidence in Elderly Persons , 1996, Annals of Internal Medicine.

[25]  I. Reid,et al.  Long-term effects of calcium supplementation on bone loss and fractures in postmenopausal women: a randomized controlled trial. , 1995, The American journal of medicine.

[26]  R. Rizzoli,et al.  Effects of calcium supplements on femoral bone mineral density and vertebral fracture rate in vitamin-D-replete elderly patients , 1994, Osteoporosis International.

[27]  R. Eastell,et al.  The effect of calcium supplementation on the circadian rhythm of bone resorption. , 1994, The Journal of clinical endocrinology and metabolism.

[28]  C. Sempos,et al.  Dietary calcium and hip fracture risk: The NHANES I Epidemiologic Follow-Up Study , 1993, Osteoporosis International.

[29]  F Duboeuf,et al.  Vitamin D3 and calcium to prevent hip fractures in elderly women. , 1992, The New England journal of medicine.

[30]  L. Melton,et al.  Black-white differences in fracture rates. , 1992, American journal of epidemiology.

[31]  B. Henderson,et al.  Exercise and Other Factors in the Prevention of Hip Fracture: The Leisure World Study , 1991, Epidemiology.

[32]  E. Barrett-Connor,et al.  DIETARY CALCIUM AND RISK OF HIP FRACTURE: 14-YEAR PROSPECTIVE POPULATION STUDY , 1988, The Lancet.

[33]  G Block,et al.  A data-based approach to diet questionnaire design and testing. , 1986, American journal of epidemiology.

[34]  H. Spencer,et al.  Calcium requirements in humans. Report of original data and a review. , 1984, Clinical orthopaedics and related research.

[35]  H. Rodbard,et al.  American Association of Clinical Endocrinologists medical guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis: 2001 edition, with selected updates for 2003. , 2003, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

[36]  G. Guyatt,et al.  Meta-Analyses of Therapies for Postmenopausal Osteoporosis , 2002 .

[37]  K. Isenberg,et al.  Nicotine and Tourettes Syndrome , 1989 .