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 |
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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 |
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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 |