Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary careBMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7498.1003 (Published 28 April 2005) Cite this as: BMJ 2005;330:1003
- 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
- Accepted 15 March 2005
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.
Details of previous trials are on bmj.com
Contributors YB was the original trial coordinator for the pilot study and helped write guidance for the practice nurses. SC was a trial coordinator and was responsible for data entry and cleaning, combining the datasets, and undertaking part of the analysis. JD assisted with data management and analysis and undertook the quality of life data analysis. CI undertook the randomisation and advised on collection of economic data. SP was assistant trial coordinator and helped enter and clean data. JP took over as trial coordinator and was responsible for recruitment to the main trial at the York centre and liaising with collaborating centres, she also undertook and supervised data entry and data management and helped draft practice nurse guidance. DJT, principal investigator, drafted the trial protocol, helped obtain funding for the main study, undertook some of the analysis, and wrote the first draft of the report. He is guarantor for the paper. IW helped draft the trial protocol, advised on primary care and clinical issues, and contributed to successive drafts of the main manuscript. TA helped draft the protocol and advised on clinical issues. RMF helped draft the protocol and advised on clinical issues. CK recruited, and managed data from, the doctors and participants for the main trial. AS helped draft the protocol and write practice nurse guidance. ES recruited doctors and participants for the main trial, managed data from participants, and helped write practice nurse guidance. MB helped recruit doctors, supervised the Hertfordshire centre, and provided primary care expertise. LS recruited doctors and participants and managed the resulting data. YB, SC, CI, SP, TA, RMF, AS, and MB commented on drafts of the paper.
Funding Grants from Northern and Yorkshire NHS research and development, healthy ageing programme (TA, RMF, AS, IW, DJT), Shire, and Nycomed. Shire supplied the calcium and vitamin D supplements. None of the funders were involved in the design, analysis, or writing up of the study.
Competing interests RMF has served as an adviser to, and spoken at meetings organised by, Shire and Nycomed. JP and SP have been sponsored by Shire to attend conferences. AS has spoken at meetings organised by Shire and served as nurse adviser. DJT has received funding from Shire and other pharmaceutical companies for research and sponsorship to attend conferences and meetings.
Ethical approval Northern and Yorkshire multicentre research ethics committee 1/3/12 and relevant local research ethics committees.
- Accepted 15 March 2005