Porthouse 2005.
Study characteristics | ||
Methods | Random allocation, initially 2:1 ratio intervention to control Remote site computer randomisation Blinding of outcome assessors not stated 3199 of 3314 completed | |
Participants | Multicentre general practice study, UK
3314 patients (all women), mean age 77 years, with at least 1 self‐reported risk factor for hip fracture Inclusion criteria: low body weight (< 58 kg), personal history of fracture, maternal history of hip fracture, current smoker, poor or fair health Disease exclusions: kidney or bladder stones, renal failure, hypercalcaemia, cognitive impairment, life expectancy < 6 months Drug exclusions: current calcium supplementation of > 500 mg/day |
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Interventions | 1. Calcium 1000 mg and vitamin D3 800 IU given as 2 tablets daily, nurse gave general lifestyle advice, and information leaflet on calcium and vitamin D and on falls prevention
Randomised 1321, completed 1269 2. Information leaflet on calcium and vitamin D and on falls prevention. Randomised 1993, completed 1930 Duration of treatment 18 to 42 months |
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Outcomes | Measured over a median follow‐up of 25 months (range 18 to 42 months) 1. Number of persons sustaining new hip fracture 2. Number of persons sustaining new non‐vertebral fracture 3. Number of persons dying | |
Notes | Prof DJ Torgerson provided pre‐publication report and further details 9‐16 February 2005 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States "randomised" |
Allocation concealment (selection bias) | Low risk | States "randomised (stratified by practice) by computer at the York Trials Unit by an independent person with no knowledge of the participants' characteristics" |