BMJ  2005;330:1003 (30 April), doi:10.1136/bmj.330.7498.1003

Primary care

Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care

Jill Porthouse, research fellow1, Sarah Cockayne, research fellow1, Christine King, personal assistant2, Lucy Saxon, research coordinator3, Elizabeth Steele, registered general nurse2, Terry Aspray, consultant geriatrician2, Mike Baverstock, general practitioner3, Yvonne Birks, research fellow1, Jo Dumville, research fellow1, Roger Francis, consultant physician2, Cynthia Iglesias, research fellow1, Suezann Puffer, research assistant1, Anne Sutcliffe, osteoporosis specialist nurse2, Ian Watt, professor of primary care1, David J Torgerson, director1

1 York Trials Unit, Department of Health Sciences, University of York, York YO10 5DD, 2 Bone Clinic, Freeman Hospital, Newcastle upon Tyne, 3 Hertfordshire Primary Care Network, Ware, Herts

Correspondence to: D J Torgerson djt6{at}york.ac.uk

Objective To assess whether supplementation with calcium and cholecaliferol (vitamin D3) reduces the risk of fracture in women with one or more risk factors for fracture of the hip.

Design Pragmatic open randomised controlled trial.

Setting Practice nurse led clinics in primary care.

Participants 3314 women aged 70 and over with one or more risk factors for hip fracture: any previous fracture, low body weight (< 58 kg), smoker, family history of hip fracture, or fair or poor self reported health.

Intervention Daily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls, or leaflet only (control group).

Main outcome measures Primary outcome measure was all clinical fractures and secondary outcome measures were adherence to treatment, falls, and quality of life (measured with the SF-12).

Results 69% of the women who completed the follow-up questionnaire at 24 months were still taking supplements (55% with inclusion of randomised participants known to be alive). After a median follow-up of 25 months (range 18 to 42 months), clinical fracture rates were lower than expected in both groups but did not significantly differ for all clinical fractures (odds ratio for fracture in supplemented group 1.01, 95% confidence interval 0.71 to 1.43). The odds ratio for hip fracture was 0.75 (0.31 to 1.78). The odds of a woman having a fall at six and 12 months was 0.99 and 0.98, respectively. Quality of life did not significantly differ between the groups.

Conclusion We found no evidence that calcium and vitamin D supplementation reduces the risk of clinical fractures in women with one or more risk factors for hip fracture.

Registration ISRCTN26118436, controlled trials registry.


Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Reddit Reddit   Add to Technorati Technorati    What's this?

Related Articles

Audit identifies the most read BMJ research papers
Susan Mayor
BMJ 2007 334: 554-555. [Extract] [Full Text] [PDF]

Calcium and vitamin D in preventing fractures: Vitamin K supplementation has powerful effect
Thomas E Radecki
BMJ 2005 331: 108. [Extract] [Full Text] [PDF]

Calcium and vitamin D in preventing fractures: Dietary intake of calcium needs to be considered
Julian R F Walters
BMJ 2005 331: 108. [Extract] [Full Text]

Calcium and vitamin D in preventing fractures: Data are not sufficient to show inefficacy
Alex Vasquez and John Cannell
BMJ 2005 331: 108-109. [Extract] [Full Text]

Calcium and vitamin D don't seem to prevent fractures
BMJ 2005 330: 0. [Full Text] [PDF]

Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trial
Daksha P Trivedi, Richard Doll, and Kay Tee Khaw
BMJ 2003 326: 469. [Abstract] [Full Text] [PDF]

This article has been cited by other articles:

  • Bischoff-Ferrari, H. A, Rees, J. R, Grau, M. V, Barry, E., Gui, J., Baron, J. A (2008). Effect of calcium supplementation on fracture risk: a double-blind randomized controlled trial. Am. J. Clin. Nutr. 87: 1945-1951 [Abstract] [Full text]  
  • MacLean, C., Newberry, S., Maglione, M., McMahon, M., Ranganath, V., Suttorp, M., Mojica, W., Timmer, M., Alexander, A., McNamara, M., Desai, S. B., Zhou, A., Chen, S., Carter, J., Tringale, C., Valentine, D., Johnsen, B., Grossman, J. (2008). Systematic Review: Comparative Effectiveness of Treatments to Prevent Fractures in Men and Women with Low Bone Density or Osteoporosis. ANN INTERN MED 148: 197-213 [Abstract] [Full text]  
  • Aspray, T. J., Francis, R. M. (2008). Vitamin D deficiency can old age learn from childhood?. Age Ageing 37: 6-7 [Full text]  
  • Francis, R. M. (2007). The Vitamin D Paradox. Rheumatology (Oxford) 46: 1749-1750 [Full text]  
  • Autier, P., Gandini, S. (2007). Vitamin D Supplementation and Total Mortality: A Meta-analysis of Randomized Controlled Trials. Arch Intern Med 167: 1730-1737 [Abstract] [Full text]  
  • Burleigh, E., McColl, J., Potter, J. (2007). Does vitamin D stop inpatients falling? A randomised controlled trial. Age Ageing 36: 507-513 [Abstract] [Full text]  
  • Holick, M. F. (2007). Vitamin D Deficiency. NEJM 357: 266-281 [Full text]  
  • Hitz, M. F, Jensen, J.-E. B, Eskildsen, P. C (2007). Bone mineral density and bone markers in patients with a recent low-energy fracture: effect of 1 y of treatment with calcium and vitamin D. Am. J. Clin. Nutr. 86: 251-259 [Abstract] [Full text]  
  • Shinchuk, L., Holick, M. F. (2007). Vitamin D and Rehabilitation: Improving Functional Outcomes. Nutr Clin Pract 22: 297-304 [Abstract] [Full text]  
  • Schwalfenberg, G. (2007). Not enough vitamin D: Health consequences for Canadians. cfp 53: 841-854 [Abstract] [Full text]  
  • Ma, J., Johns, R. A, Stafford, R. S (2007). Americans are not meeting current calcium recommendations. Am. J. Clin. Nutr. 85: 1361-1366 [Abstract] [Full text]  
  • Heaney, R. P (2007). Bone health. Am. J. Clin. Nutr. 85: 300S-303S [Abstract] [Full text]  
  • Law, M., Withers, H., Morris, J. (2006). Reply. Age Ageing 35: 645-645 [Full text]  
  • Zermansky, A. G., Alldred, D. P., Petty, D. R., Raynor, D. K., Freemantle, N., Eastaugh, J., Bowie, P. (2006). Clinical medication review by a pharmacist of elderly people living in care homes--randomised controlled trial. Age Ageing 35: 586-591 [Abstract] [Full text]  
  • Law, M., Withers, H., Morris, J., Anderson, F. (2006). Vitamin D supplementation and the prevention of fractures and falls: results of a randomised trial in elderly people in residential accommodation. Age Ageing 35: 482-486 [Abstract] [Full text]  
  • Aspray, T. J., Francis, R. M. (2006). Fracture prevention in care home residents: is vitamin D supplementation enough?. Age Ageing 35: 455-456 [Full text]  
  • Bischoff-Ferrari, H. A, Giovannucci, E., Willett, W. C, Dietrich, T., Dawson-Hughes, B. (2006). Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes. Am. J. Clin. Nutr. 84: 18-28 [Abstract] [Full text]  
  • Cockayne, S., Adamson, J., Lanham-New, S., Shearer, M. J., Gilbody, S., Torgerson, D. J. (2006). Vitamin K and the Prevention of Fractures: Systematic Review and Meta-analysis of Randomized Controlled Trials.. Arch Intern Med 166: 1256-1261 [Abstract] [Full text]  
  • Liu, H., Michaud, K., Nayak, S., Karpf, D. B., Owens, D. K., Garber, A. M. (2006). The Cost-effectiveness of Therapy With Teriparatide and Alendronate in Women With Severe Osteoporosis.. Arch Intern Med 166: 1209-1217 [Abstract] [Full text]  
  • Francis, R.M., Anderson, F.H., Patel, S., Sahota, O., van Staa, T.P. (2006). Calcium and vitamin D in the prevention of osteoporotic fractures. QJM 99: 355-363 [Full text]  
  • Jackson, R. D., LaCroix, A. Z., Gass, M., Wallace, R. B., Robbins, J., Lewis, C. E., Bassford, T., Beresford, S. A.A., Black, H. R., Blanchette, P., Bonds, D. E., Brunner, R. L., Brzyski, R. G., Caan, B., Cauley, J. A., Chlebowski, R. T., Cummings, S. R., Granek, I., Hays, J., Heiss, G., Hendrix, S. L., Howard, B. V., Hsia, J., Hubbell, F. A., Johnson, K. C., Judd, H., Kotchen, J. M., Kuller, L. H., Langer, R. D., Lasser, N. L., Limacher, M. C., Ludlam, S., Manson, J. E., Margolis, K. L., McGowan, J., Ockene, J. K., O'Sullivan, M. J., Phillips, L., Prentice, R. L., Sarto, G. E., Stefanick, M. L., Van Horn, L., Wactawski-Wende, J., Whitlock, E., Anderson, G. L., Assaf, A. R., Barad, D., the Women's Health Initiative Investigators, (2006). Calcium plus Vitamin D Supplementation and the Risk of Fractures. NEJM 354: 669-683 [Abstract] [Full text]  
  • Finkelstein, J. S. (2006). Calcium plus Vitamin D for Postmenopausal Women -- Bone Appetit?. NEJM 354: 750-752 [Full text]  
  • (2006). Vitamin Supplements. Obstet Gynecol 107: 174-176 [Full text]  
  • Liu, R. H., Albrecht, J., Werth, V. P. (2006). Cross-sectional Study of Bisphosphonate Use in Dermatology Patients Receiving Long-term Oral Corticosteroid Therapy. Arch Dermatol 142: 37-41 [Abstract] [Full text]  
  • (2005). ADDITIONAL ARTICLES ABSTRACTED IN ACP JOURNAL CLUB. Evid. Based Med. 10: 188-188 [Full text]  
  • Cole, P. A., Bhandari, M. (2005). What's New in Orthopaedic Trauma. JBJS 87: 2823-2838 [Full text]  
  • Allain, T. J. (2005). Vitamin D and fracture prevention--treatment still indicated but clarification needed. Age Ageing 34: 542-544 [Full text]  
  • (2005). Calcium and vitamin D is effective for preventing first fracture. BMJ 331: - [Full text]  
  • Radecki, T. E (2005). Calcium and vitamin D in preventing fractures: Vitamin K supplementation has powerful effect. BMJ 331: 108-108 [Full text]  
  • Walters, J. R F (2005). Calcium and vitamin D in preventing fractures: Dietary intake of calcium needs to be considered. BMJ 331: 108-108 [Full text]  
  • Vasquez, A., Cannell, J. (2005). Calcium and vitamin D in preventing fractures: Data are not sufficient to show inefficacy. BMJ 331: 108-109 [Full text]  
  • (2005). Does Vitamin D Supplementation Prevent Fractures?. Journal Watch Dermatology 2005: 10-10 [Full text]  
  • (2005). Does Vitamin D Supplementation Prevent Fractures?. JWatch General 2005: 2-2 [Full text]  

Rapid Responses:

Read all Rapid Responses

What about vitamin K
Thomas E Radecki
bmj.com, 1 May 2005 [Full text]
D-vitamin
Bengt H Möller
bmj.com, 1 May 2005 [Full text]
An analogy that may help readers understand this unique study design.
Reinhold Vieth
bmj.com, 1 May 2005 [Full text]
Zinc and magnesium supplements, not calcium supplements, are needed in osteoporosis
Ellen C G Grant
bmj.com, 5 May 2005 [Full text]
Calcium, vitamin D and Aromatase inhibitors
Hazel Thornton
bmj.com, 2 May 2005 [Full text]
Subphysiologic Doses of Vitamin D are Subtherapeutic: Comment on the Study by Porthouse and colleagues
Alex Vasquez, et al.
bmj.com, 4 May 2005 [Full text]
Calcium intake, absorption and hip fractures
Julian RF Walters
bmj.com, 5 May 2005 [Full text]
Calcium and vitamin D supplementation for prevention of fractures: a flawed study
Peter J Lewis
bmj.com, 9 May 2005 [Full text]
Adherence rate
M Berends
bmj.com, 11 May 2005 [Full text]
More on vitamin D and fracture prevention
Peter J Lewis
bmj.com, 11 May 2005 [Full text]
Calcium and vitamin D supplement in a calcium and vitamin D replete population
Pierre J. Meunier
bmj.com, 18 May 2005 [Full text]
supplementation with calcium and cholecalciferol
Alan W Fowler
bmj.com, 19 May 2005 [Full text]
Vitamin D and Calcium for fracture prevention in primary care
Stephan H Scharla
bmj.com, 26 May 2005 [Full text]
The value of clinical trial registry
Daniela M Gallo, et al.
bmj.com, 9 Jul 2005 [Full text]
Biochemists' perspective
Anand C V, et al.
bmj.com, 4 Aug 2005 [Full text]

Student BMJ

Intimate examinations

Israeli students are refusing to perform intimate examinations on anaesthetised women without their informed consent.

www.student.bmj.com

Listen to the latest BMJ Interview