RECORD

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.

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.

Contacts

• Alison Avenell; a.avenell@abdn.ac.uk

Status

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.