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. 2014 Apr 14;2014(4):CD000227. doi: 10.1002/14651858.CD000227.pub4

Chapuy 2002.

Study characteristics
Methods Random allocation. No further details provided
Double‐masked, placebo‐controlled study, blinding of outcome assessors not confirmed
Completion rate unclear
Participants Residents of 55 apartment houses for elderly people, in France
610 or 583 (number unclear) women, mean age 85 years
Inclusion criteria: ambulatory (able to walk indoors with cane or walker), life expectancy of at least 24 months
Disease exclusions: intestinal malabsorption, hypercalcaemia (serum calcium > 2.63 mmol/L), chronic renal failure (serum creatinine > 150 μmol/L)
Drug exclusions: received drugs known to alter bone metabolism, such as corticosteroids, anticonvulsants or a high dose of thyroxine, in the past year. Fluoride salts (> 3 months), bisphosphonates, calcitonin (> 1 month), calcium (> 500 mg daily), vitamin D (> 100 IU daily) in last 12 months
Interventions 1. Calcium 1200 mg as tricalcium phosphate and vitamin D3 800 IU daily as 1 sachet
2. Calcium 1200 mg as tricalcium phosphate sachet and 2 pills of vitamin D3 400 IU daily
Groups 1 and 2: randomised 389, completed unclear
3. 1 placebo sachet and 2 placebo tablets daily. Randomised 194, completed unclear
Duration of treatment 2 years
Outcomes Measured over a follow‐up of 2 years
1. Number of persons sustaining new hip fracture
2. Number of persons sustaining new non‐vertebral fracture
3. Numbers of persons developing hypercalcaemia
4. Number of persons dying
5. Number of persons reporting gastrointestinal disorders
6. PTH, 25(OH)D
7. BMD of distal radius, femoral neck BMD, ultrasound of os calcis
Notes Prof Meunier provided further details on outcomes 28 February 2005, confirming 194 in placebo group and 389 in calcium and vitamin D groups combined
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk States "randomized", no other information provided
Allocation concealment (selection bias) Unclear risk No details provided