Skip to main content
. 2014 Apr 14;2014(4):CD000227. doi: 10.1002/14651858.CD000227.pub4

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
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
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"