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

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posted on 2023-06-08, 12:04 authored by B Abrahamsen, T Masud, A Avenell, F Anderson, H E Meyer, C Cooper, Helen Smith, A Z LaCroix, D Torgerson, A Johansen, R Jackson, L Rejnmark, J Wactawski-Wende, K Brixen, L Mosekilde, J A Robbins, R M Francis
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.

History

Publication status

  • Published

File Version

  • Published version

Journal

BMJ

ISSN

0959-8138

Publisher

BMJ Publishing Group

Volume

340

Article number

b5463

Department affiliated with

  • Primary Care and Public Health Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2012-07-13

First Open Access (FOA) Date

2012-07-13

First Compliant Deposit (FCD) Date

2012-07-03

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