Inkovaara 1983.
Study characteristics | ||
Methods | Quasi‐randomised by date of birth Double‐blind placebo‐controlled trial, blinding of outcome assessors not described 121 of 175 completed in the 4 groups examined in this review | |
Participants | Community‐based study, Finland
143 women and 32 men living in a municipal home for the aged. Mean age 79.5 years SD 7.1 Exclusions: functional disorders of kidneys (serum creatinine > 150 μmol/L) or liver (AAT > 40 IU/L or APT > 280 IU/L, hypercalcaemia (serum Ca 2.80 mmol/L) or kidney stones |
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Interventions | 1. Calcium plus vitamin D3 daily with placebo
Randomised 46 completed 30 2. Vitamin D3 1000 IU daily with double placebo Randomised 45 completed 32 3. Elemental calcium 1.2 g daily, with double placebo Randomised 42 completed 31 4. Placebo Randomised 42 completed 28 4 additional groups had methanedione alone or in combination: these groups are not analysed in this review Duration of treatment 9 months |
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Outcomes | Measured at 1 year 1. Fractures of vertebrae or wrist (assessed in a sample N = 10 in each group) 2. Hypercalcaemia 3. Number of persons dying 4. Body weight 5. Serum biochemistry: calcium, phosphate, creatinine, alkaline phosphatase, aspartate aminotransferase | |
Notes | Unclear whether the data represent fractures or participants with fractures. Data have not been included in the appropriate meta‐analyses | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | States "Patients were divided into 8 groups according to year and month of birth" |
Allocation concealment (selection bias) | Unclear risk | States "A double‐blind trial technique was used. The code was known only to the drug manufacturer" |