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Patient level pooled analysis of 68,500 patients from seven major vitamin D fracture trials in US and Europe

Record type: Article

Objectives: to identify participants’ characteristics that influence the anti-fracture efficacy of vitamin D or vitamin D plus calcium with respect to any fracture, hip fracture, and clinical vertebral fracture and to assess the influence of dosing regimens and co-administration of calcium.
Design Individual patient data analysis using pooled data from randomised trials.

Data sources: seven major randomised trials of vitamin D with calcium or vitamin D alone, yielding a total of 68 517 participants (mean age 69.9 years, range 47-107 years, 14.7% men).

Study selection: studies included were randomised studies with at least one intervention arm in which vitamin D was given, fracture as an outcome, and at least 1000 participants.

Data synthesis: logistic regression analysis was used to identify significant interaction terms, followed by Cox’s proportional hazards models incorporating age, sex, fracture history, and hormone therapy and bisphosphonate use.

Results: trials using vitamin D with calcium showed a reduced overall risk of fracture (hazard ratio 0.92, 95% confidence interval 0.86 to 0.99, P=0.025) and hip fracture (all studies: 0.84, 0.70 to 1.01, P=0.07; studies using 10 µg of vitamin D given with calcium: 0.74, 0.60 to 0.91, P=0.005). For vitamin D alone in daily doses of 10 µg or 20 µg, no significant effects were found. No interaction was found between fracture history and treatment response, nor any interaction with age, sex, or hormone replacement therapy.

Conclusion: this individual patient data analysis indicates that vitamin D given alone in doses of 10-20 µg is not effective in preventing fractures. By contrast, calcium and vitamin D given together reduce hip fractures and total fractures, and probably vertebral fractures, irrespective of age, sex, or previous fractures.

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Citation

Abrahamsen, B., Masud, T., Avenell, A., Anderson, F., Meyer, H.E. and Cooper, C. DIPART (Vitamin D Individual Patient Analyses of Randomised Trials) Group (2010) Patient level pooled analysis of 68,500 patients from seven major vitamin D fracture trials in US and Europe BMJ, 340, b5463. (doi:10.1136/bmj.b5463). (PMID:20068257).

More information

Published date: 12 January 2010
Organisations: Medicine

Identifiers

Local EPrints ID: 150241
URI: http://eprints.soton.ac.uk/id/eprint/150241
ISSN: 0959-8138
PURE UUID: ef4607e7-9a3c-4260-a0ff-20e85d8cabbc

Catalogue record

Date deposited: 04 May 2010 15:30
Last modified: 18 Jul 2017 19:18

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Contributors

Author: B. Abrahamsen
Author: T. Masud
Author: A. Avenell
Author: F. Anderson
Author: H.E. Meyer
Author: C. Cooper

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