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

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
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
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"