Harwood 2004.
Study characteristics | ||
Methods | Random allocation Computer‐generated random number lists and opaque, sealed envelopes Blinding of outcome assessors stated 119 of 150 completed | |
Participants | Community‐based study, UK
150 women, mean age 81.2 years on fast‐tract orthogeriatric rehabilitation ward Inclusion criteria: within 7 days of surgery for hip fracture, community residence and independent in activities of daily living Disease exclusions: institutionalised, diseases known to affect bone metabolism, abbreviated mental test score < 7 at time of recruitment Drug exclusions: medications know to affect bone metabolism |
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Interventions | 1. Vitamin D2 300,000 IU by injection once at beginning of trial
Randomised 38, completed 30 2. Vitamin D2 300,000 IU by injection once at beginning of trial and calcium 1000 mg daily as 2 tablets Randomised 36, completed 25 3. Vitamin D3 800 IU and calcium 1000 mg daily as 2 tablets Randomised 39, completed 29 4. No trial treatment Randomised 37, completed 35 Duration of treatment 1 year |
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Outcomes | Measured over follow‐up of 1 year 1. Number of persons sustaining new non‐vertebral fracture 2. Number of persons sustaining hew hip fracture 3. Number of persons dying 4. Number of persons developing hypercalcaemia 5. BMD of lumbar spine and proximal femur 6. PTH, 1,25(OH)2D and 25(OH)D3 | |
Notes | Dr R Harwood provided further details of fractures and deaths 24 January 2003 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | States "computer‐generated random number lists" |
Allocation concealment (selection bias) | Low risk | States "Computer‐generated random number lists and opaque, sealed envelopes" |