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.
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| Title: | 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. |
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| Authors: | Grant, A.M., Anderson, F.H., Avenell, A., Campbell, M.K., Cooper, C., Donaldson, C., Francis, R.M., Gillespie, W.J., Robinson, C.M., Torgerson, D.J., Wallace, W.A., McPherson, G.C., MacLennan, G.S., McDonald, A.M. |
| Source: | Lancet. 5/7/2005, Vol. 365 Issue 9471, p1621-1628. 8p. 1 Diagram, 5 Charts, 1 Graph. |
| Subjects: | Risk factors of fractures, Bone injuries, Older people's injuries, Therapeutic use of vitamin D, Calcium, Clinical trials, Therapeutics |
| 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. [ABSTRACT FROM AUTHOR] |
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| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Links: – Type: pdflink Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 16972756 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: 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. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Grant%2C+A%2EM%2E%22">Grant, A.M.</searchLink><br /><searchLink fieldCode="AR" term="%22Anderson%2C+F%2EH%2E%22">Anderson, F.H.</searchLink><br /><searchLink fieldCode="AR" term="%22Avenell%2C+A%2E%22">Avenell, A.</searchLink><br /><searchLink fieldCode="AR" term="%22Campbell%2C+M%2EK%2E%22">Campbell, M.K.</searchLink><br /><searchLink fieldCode="AR" term="%22Cooper%2C+C%2E%22">Cooper, C.</searchLink><br /><searchLink fieldCode="AR" term="%22Donaldson%2C+C%2E%22">Donaldson, C.</searchLink><br /><searchLink fieldCode="AR" term="%22Francis%2C+R%2EM%2E%22">Francis, R.M.</searchLink><br /><searchLink fieldCode="AR" term="%22Gillespie%2C+W%2EJ%2E%22">Gillespie, W.J.</searchLink><br /><searchLink fieldCode="AR" term="%22Robinson%2C+C%2EM%2E%22">Robinson, C.M.</searchLink><br /><searchLink fieldCode="AR" term="%22Torgerson%2C+D%2EJ%2E%22">Torgerson, D.J.</searchLink><br /><searchLink fieldCode="AR" term="%22Wallace%2C+W%2EA%2E%22">Wallace, W.A.</searchLink><br /><searchLink fieldCode="AR" term="%22McPherson%2C+G%2EC%2E%22">McPherson, G.C.</searchLink><br /><searchLink fieldCode="AR" term="%22MacLennan%2C+G%2ES%2E%22">MacLennan, G.S.</searchLink><br /><searchLink fieldCode="AR" term="%22McDonald%2C+A%2EM%2E%22">McDonald, A.M.</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 5/7/2005, Vol. 365 Issue 9471, p1621-1628. 8p. 1 Diagram, 5 Charts, 1 Graph. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Risk+factors+of+fractures%22">Risk factors of fractures</searchLink><br /><searchLink fieldCode="DE" term="%22Bone+injuries%22">Bone injuries</searchLink><br /><searchLink fieldCode="DE" term="%22Older+people's+injuries%22">Older people's injuries</searchLink><br /><searchLink fieldCode="DE" term="%22Therapeutic+use+of+vitamin+D%22">Therapeutic use of vitamin D</searchLink><br /><searchLink fieldCode="DE" term="%22Calcium%22">Calcium</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink><br /><searchLink fieldCode="DE" term="%22Therapeutics%22">Therapeutics</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: 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. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1016/S0140-6736(05)63013-9 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 8 StartPage: 1621 Subjects: – SubjectFull: Risk factors of fractures Type: general – SubjectFull: Bone injuries Type: general – SubjectFull: Older people's injuries Type: general – SubjectFull: Therapeutic use of vitamin D Type: general – SubjectFull: Calcium Type: general – SubjectFull: Clinical trials Type: general – SubjectFull: Therapeutics Type: general Titles: – TitleFull: 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. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Grant, A.M. – PersonEntity: Name: NameFull: Anderson, F.H. – PersonEntity: Name: NameFull: Avenell, A. – PersonEntity: Name: NameFull: Campbell, M.K. – PersonEntity: Name: NameFull: Cooper, C. – PersonEntity: Name: NameFull: Donaldson, C. – PersonEntity: Name: NameFull: Francis, R.M. – PersonEntity: Name: NameFull: Gillespie, W.J. – PersonEntity: Name: NameFull: Robinson, C.M. – PersonEntity: Name: NameFull: Torgerson, D.J. – PersonEntity: Name: NameFull: Wallace, W.A. – PersonEntity: Name: NameFull: McPherson, G.C. – PersonEntity: Name: NameFull: MacLennan, G.S. – PersonEntity: Name: NameFull: McDonald, A.M. IsPartOfRelationships: – BibEntity: Dates: – D: 07 M: 05 Text: 5/7/2005 Type: published Y: 2005 Identifiers: – Type: issn-print Value: 01406736 Numbering: – Type: volume Value: 365 – Type: issue Value: 9471 Titles: – TitleFull: Lancet Type: main |
| ResultId | 1 |