Summary

Osteoporotic fractures are a major cause of ill-health in older people. The most promising prevention strategy for the elderly, amongst whom most fractures occur, is supplementation with a combination of vitamin D and calcium. Evidence for vitamin D alone is much weaker, but if clinically effective this would be more appropriate and cost effective. The aim of this placebo-controlled randomised controlled trial (with factorial design) was, therefore, to evaluate the effects of vitamin D and calcium alone and in combination on new fractures, health care resources, and quality of life.

Contact

Alison Avenell - a.avenell@abdn.ac.uk

Status

Completed

Findings

5292 participants were recruited to the trial from 21 UK hospitals and were followed up for between 24 and 62 months. 689 (13%) sustained a further low-trauma fracture including 183 with hip fractures. There were no statistically significant differences between those allocated calcium and those not; those allocated vitamin D and those not; and those allocated both calcium and vitamin D versus placebo. The findings do not support the routine use of calcium and/or vitamin D for the prevention of further fractures in older people with a recent low-trauma fracture.

Publications

Referred Articles

Avenell A, MacLennan GS, Jenkinson DJ, McPherson GC, McDonald AM, Pant PR, et al. Long-term follow-up for mortality and cancer in a randomized placebo-controlled trial of vitamin D3 and/or calcium (RECORD trial) ISRCTN 51647438. J Clin Endocrinol Metab2012; 97: 614-622

The RECORD Trial Group, [Grant AM], [Avenell A], [Campbell MK], [McDonald A], [MacLennan GS], [McPherson G]. 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. Lancet 2005;365:1621-1628.

Avenell A, Cook JA, MacLennan GS, MacPherson GC for The RECORD Trial Group. Vitamin D supplementation to prevent infections: a sub study of a randomised placebo-controlled trial in older people (RECORD trial, ISRCTN 51647438). Age and Ageing 2007; 36: 574-77.

Avenell A, Cook JA, MacLennan GS, MacPherson GC for The RECORD Trial Group Vitamin D supplementation and type 2 diabetes: a sub study of a randomised placebo-controlled trial in older people (RECORD trial, ISRCTN 51647438). Age Ageing 2009; 38: 606-9.

Avenell A, Grant AM, McGee M, McPherson G, Campbell MK, McGee MA et al. The effects of an open design on trial participant recruitment, compliance and retention - a randomised controlled trial comparison with a blinded, placebo-controlled design. Clin Trials 2004;1(6):490-498.

McDonald A, Campbell MK, Ross S, for the RECORD Study Group. Delivering clinical trial supplies by post to elderly trial participants: a feasibility study. Appl Clin Trial 2004;(Feb):58-59.

Grant AM, RECORD Project Management Group. Protocol 02PRT/35. Randomised placebo-controlled trial of daily oral vitamin D and calcium for the secondary prevention of osteoporosis-related fractures in the elderly. (RECORD). Lancet 2003;365(9471):1621-1628.

Other Journal Publications

Avenell, A., for the RECORD Study Group, [Grant AM], and [Campbell MK]. Vitamin D and the MRC RECORD Trial [letter]. BMJ [serial on the Internet] 1999. Available from: http://www.bmj.com/cgi/eletters/319/702/114

McDonald A, Campbell MK, Ross S, RECORD Study Group.   Delivering clinical trial supplies by post to elderly trial participants: a feasibility study Appl Clin Trial. 2004;(Feb):58-59

Published Abstracts

Grant AM, Anderson FH , for the RECORD Trial Management Group, [Campbell MK], [Avenell A]. The Medical Research Council RECORD trial: An evaluation of calcium and/or vitamin D in the secondary prevention of osteoporotic fractures [abstract]. Osteoporosis Int 2005;15(( Suppl 2)):S13.

McDonald A, McPherson G, Campbell MK, for the RECORD Study Group. Could the appearance of postal questionnaires influence response? Observations from the UK RECORD trials.[abstract]. Clin Trials 2004;2004(2):244.

McPherson G, McDonald A, Campbell MK. Postal questionnaires - level of completion of the SF12 and EQ-5D observations from the UK RECORD trial.[abstract]. Clin Trials 2004;1(2):236-237.

Avenell A, Grant AM, McGee M, McPherson G, Campbell MK, McGee MA. Is recruitment easier with an open rather than blinded, placebo-controlled design? A randomised controlled trial [abstract]. Control Clin Trials 2003;24( Suppl ):172S.

McDonald A, Campbell M, Ross S. Delivering clinical trial supplies by post to frail elderly subjects: a feasibility study [abstract]. Control Clin Trials 2000;21:110s-111s.

Conference Presentations

Grant AM, Anderson FH, for the RECORD Trial Management Group. The Medical Research Council RECORD trial: An evaluation of calcium and/or vitamin D in the secondary prevention of osteoporotic fractures [oral presentation]. . National Osteoporosis Society 10th Conference on Osteoporosis, Harrogate, 28 November-1 December 2004.

Grant AM, Wallace WA, Gillespie W, Robinson CM, for the RECORD Trial Management Group, [Campbell MK] et al. The outcome for the RECORD trial: An evaluation of calcium and/or vitamin D on the secondary prevention of osteoporotic fractures [oral presentation]. British Orthopaedic Association: Annual Congress 2004, Manchester 15-17 September 2004.

McPherson G, McDonald A, Campbell MK, for the RECORD Study Group. Level of completion of the SF12 and EQ-5D in postal questionnaires. Observation from the MRC RECORD Trial [poster presentation]. Society for Social Medicine, 47th Annual Scientific Meeting, Edinburgh, 17-19 September 2003.

McDonald A, McPherson G, Campbell MK. Postal questionnaires - Does the appearance influence response? Observations for the MRC RECORD trial [poster presentation]. International Society of Technology Assessment in Health Care, 19th Annual Meeting, Canmore, Canada, 22-25 June 2003.

McPherson G, McDonald A, Campbell MK. Postal questionnaires - Do participants complete all parts of the SF12 and EQ-5D? Observations from the MRC RECORD trial [poster presentation]. International Society of Technology Assessment in Health Care, 19th Annual Meeting, Canmore, Canada, 22-25 June 2003.

McPherson G, Avenell A, Grant AM, McGee M, Campbell MK, McGee M. Is recruitment easier with an open rather than a blinded, placebo-controlled design? A randomised controlled trial [poster presentation]. International Society of Technology Assessment in Health Care, 19th Annual Meeting, Canmore, Canada, 22-25 June 2003.

Cooper C, for the RECORD Study Group, [Campbell MK], [Grant AM], [McDonald A]. Design of the RECORD trial: An evaluation of calcium and/or vitamin D in the secondary prevention of osteoporotic fractures [poster presentation]. 8th World Wide Conference of Osteoporosis Patient Societies, Lisbon Portugal, 7-8 May 2002.