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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

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
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
Background: Elderly people who have a fracture are at high risk of another. Vitamin D and calcium supplements are often recommended for fracture prevention. We aimed to assess whether vitamin D3 and calcium, either alone or in combination, were effective in prevention of secondary fractures.
Methods: In a factorial-design trial, 5292 people aged 70 years or older (4481 [85%] of whom were women) who were mobile before developing a low-trauma fracture were randomly assigned 800 IU daily oral vitamin D3, 1000 mg calcium, oral vitamin D3 (800 IU per day) combined with calcium (1000 mg per day), or placebo. Participants who were recruited in 21 UK hospitals were followed up for between 24 months and 62 months. Analysis was by intention-to-treat and the primary outcome was new low-energy fractures.
Findings: 698 (13%) of 5292 participants had a new low-trauma fracture, 183 (26%) of which were of the hip. The incidence of new, low-trauma fractures did not differ significantly between participants allocated calcium and those who were not (331 [12·6%] of 2617 vs 367 [13·7%] of 2675; hazard ratio (HR) 0·94 [95% CI 0·81–1·09]); between participants allocated vitamin D3 and those who were not (353 [13·3%] of 2649 vs 345 [13·1%] of 2643; 1·02 [0·88–1·19]); or between those allocated combination treatment and those assigned placebo (165 [12·6%] of 1306 vs 179 [13·4%] of 1332; HR for interaction term 1·01 [0·75–1·36]). The groups did not differ in the incidence of all-new fractures, fractures confirmed by radiography, hip fractures, death, number of falls, or quality of life. By 24 months, 2886 (54·5%) of 5292 were still taking tablets, 451 (8·5%) had died, 58 (1·1%) had withdrawn, and 1897 (35·8%) had stopped taking tablets but were still providing data for at least the main outcomes. Compliance with tablets containing calcium was significantly lower (difference: 9·4% [95% CI 6·6–12·2]), partly because of gastrointestinal symptoms. However, potentially serious adverse events were rare and did not differ between groups.
Interpretation: The findings do not support routine oral supplementation with calcium and vitamin D3, either alone or in combination, for the prevention of further fractures in previously mobile elderly people.
0140-6736
1621-1628
Grant, A.M.
12cf0f31-9d00-4628-ac1e-9d137ec0c1fc
Avenell, A.
21d12910-39fb-4fc3-bf29-d748641ac6fd
Campbell, M.K.
18df1510-8e81-4366-96b0-d732536b1770
McDonald, A.M.
cd46cc6c-2448-4dd3-b7b4-c5061ab1e26e
MacLennan, G.S.
57e7f9c4-2fe6-421d-8756-eecb95296dce
McPherson, G.C.
e2e35886-fdbf-44d6-b9ed-400a077ba586
Anderson, F.H.
ed26ec76-5200-4927-b39a-3f96f8ffeb43
Cooper, C.
e05f5612-b493-4273-9b71-9e0ce32bdad6
Francis, R.M.
24c83ccf-43d2-4a8d-b3db-7ef2ea0241f7
Donaldson, C.
195dd257-8ac5-417e-a64f-0d92614e894b
Gillespie, W.J.
e13c12d5-fbb0-4e57-9143-d067fcc5424a
Robinson, C.M.
9f6ab9fd-d782-4d1e-b74d-520480bd6b82
Torgerson, D.J.
b6219ee6-e47a-48da-8c5c-f54c8aff1a26
Wallace, W.A.
b559076e-7fd0-478e-a6ad-91cdc0d20767
Grant, A.M.
12cf0f31-9d00-4628-ac1e-9d137ec0c1fc
Avenell, A.
21d12910-39fb-4fc3-bf29-d748641ac6fd
Campbell, M.K.
18df1510-8e81-4366-96b0-d732536b1770
McDonald, A.M.
cd46cc6c-2448-4dd3-b7b4-c5061ab1e26e
MacLennan, G.S.
57e7f9c4-2fe6-421d-8756-eecb95296dce
McPherson, G.C.
e2e35886-fdbf-44d6-b9ed-400a077ba586
Anderson, F.H.
ed26ec76-5200-4927-b39a-3f96f8ffeb43
Cooper, C.
e05f5612-b493-4273-9b71-9e0ce32bdad6
Francis, R.M.
24c83ccf-43d2-4a8d-b3db-7ef2ea0241f7
Donaldson, C.
195dd257-8ac5-417e-a64f-0d92614e894b
Gillespie, W.J.
e13c12d5-fbb0-4e57-9143-d067fcc5424a
Robinson, C.M.
9f6ab9fd-d782-4d1e-b74d-520480bd6b82
Torgerson, D.J.
b6219ee6-e47a-48da-8c5c-f54c8aff1a26
Wallace, W.A.
b559076e-7fd0-478e-a6ad-91cdc0d20767

Grant, A.M., Avenell, A., Campbell, M.K., McDonald, A.M., MacLennan, G.S., McPherson, G.C., Anderson, F.H., Cooper, C., Francis, R.M., Donaldson, C., Gillespie, W.J., Robinson, C.M., Torgerson, D.J. and Wallace, W.A. (2005) 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. The Lancet, 365 (9471), 1621-1628. (doi:10.1016/S0140-6736(05)63013-9).

Record type: Article

Abstract

Background: Elderly people who have a fracture are at high risk of another. Vitamin D and calcium supplements are often recommended for fracture prevention. We aimed to assess whether vitamin D3 and calcium, either alone or in combination, were effective in prevention of secondary fractures.
Methods: In a factorial-design trial, 5292 people aged 70 years or older (4481 [85%] of whom were women) who were mobile before developing a low-trauma fracture were randomly assigned 800 IU daily oral vitamin D3, 1000 mg calcium, oral vitamin D3 (800 IU per day) combined with calcium (1000 mg per day), or placebo. Participants who were recruited in 21 UK hospitals were followed up for between 24 months and 62 months. Analysis was by intention-to-treat and the primary outcome was new low-energy fractures.
Findings: 698 (13%) of 5292 participants had a new low-trauma fracture, 183 (26%) of which were of the hip. The incidence of new, low-trauma fractures did not differ significantly between participants allocated calcium and those who were not (331 [12·6%] of 2617 vs 367 [13·7%] of 2675; hazard ratio (HR) 0·94 [95% CI 0·81–1·09]); between participants allocated vitamin D3 and those who were not (353 [13·3%] of 2649 vs 345 [13·1%] of 2643; 1·02 [0·88–1·19]); or between those allocated combination treatment and those assigned placebo (165 [12·6%] of 1306 vs 179 [13·4%] of 1332; HR for interaction term 1·01 [0·75–1·36]). The groups did not differ in the incidence of all-new fractures, fractures confirmed by radiography, hip fractures, death, number of falls, or quality of life. By 24 months, 2886 (54·5%) of 5292 were still taking tablets, 451 (8·5%) had died, 58 (1·1%) had withdrawn, and 1897 (35·8%) had stopped taking tablets but were still providing data for at least the main outcomes. Compliance with tablets containing calcium was significantly lower (difference: 9·4% [95% CI 6·6–12·2]), partly because of gastrointestinal symptoms. However, potentially serious adverse events were rare and did not differ between groups.
Interpretation: The findings do not support routine oral supplementation with calcium and vitamin D3, either alone or in combination, for the prevention of further fractures in previously mobile elderly people.

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Published date: 2005
Organisations: Dev Origins of Health & Disease

Identifiers

Local EPrints ID: 25555
URI: http://eprints.soton.ac.uk/id/eprint/25555
ISSN: 0140-6736
PURE UUID: 1149d37b-f6ba-46df-aa26-b71c231880b1
ORCID for C. Cooper: ORCID iD orcid.org/0000-0003-3510-0709

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Date deposited: 07 Apr 2006
Last modified: 16 Aug 2024 01:35

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Contributors

Author: A.M. Grant
Author: A. Avenell
Author: M.K. Campbell
Author: A.M. McDonald
Author: G.S. MacLennan
Author: G.C. McPherson
Author: F.H. Anderson
Author: C. Cooper ORCID iD
Author: R.M. Francis
Author: C. Donaldson
Author: W.J. Gillespie
Author: C.M. Robinson
Author: D.J. Torgerson
Author: W.A. Wallace

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