Reid 2006.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: Auckland, New Zealand N = 1471 Sample: women recruited by advertisement and mail‐outs using electoral rolls Age (years): mean 74.2 (SD 4.3) Inclusion criteria: consenting; aged > 55; more than 5 yr postmenopausal Exclusion criteria: free of major ongoing disease including serum creatinine > 1.8 mg/dl (0.2 mmol/litre), untreated hypo‐ or hyperthyroidism, liver disease, serum 25‐hydroxyvitamin D < 10 µg /litre (25 nmol/litre), malignancy, or metabolic bone disease; regular user in the previous year of hormone replacement therapy, anabolic steroids, glucocorticoids, or bisphosphonates; lumbar spine bone density below the age‐appropriate normal range (i.e. z‐score greater than ‐2) |
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Interventions | 1. Intervention: calcium citrate 1 g/day in 2 divided doses 2. Control: identical placebo |
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Outcomes | 1. Falls per person year reported 2. Number sustaining a fracture Other outcomes reported but not included in this review. Falls are a secondary outcome in this study |
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Duration of the study | 5 years | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Treatments were allocated randomly using a minimization algorithm balancing for current thiazide use, age, and the occurrence of fractures resulting from minimal trauma after the age of 40 yr." |
Allocation concealment (selection bias) | Low risk | Quote: "Subject numbers were allocated and medication was dispensed by staff who had no direct contact with the other study staff or the subjects." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | States "double blind" and "medication was dispensed by staff who had no direct contact with the other study staff or the subjects" |
Blinding of outcome assessment (detection bias) Falls and fallers | Unclear risk | Insufficient information about ascertainment of falls to permit judgement |
Blinding of outcome assessment (detection bias) Fractures | Low risk | States "double blind" and "medication was dispensed by staff who had no direct contact with the other study staff or the subjects". Subjects were asked at each 6‐month visit about fractures. If reported, the relevant radiograph or report was obtained. |
Incomplete outcome data (attrition bias) Falls | Low risk | SeeAppendix 3 for method of assessment |
Risk of bias in recall of falls | Unclear risk | "Subjects kept a diary of falls." Details unclear. |