Tilyard 1992.
Study characteristics | ||
Methods | Multi‐centre randomised single‐blind comparison of calcitriol and calcium supplementation. No placebo, and each participating physician (123) had own separate randomisation code. Participant compliance not checked 515 of 622 completed at 1 year, 476 at 2 years, 432 at 3 years | |
Participants | Community‐based study, New Zealand
622 fully ambulatory post‐menopausal women aged 50 to 79 years (mean 63.7 years) with no evidence of disease or drug known to cause osteoporosis, from a population referred with fracture or other manifestation of effects of osteoporosis Inclusion criteria: presence of 1 or more non‐traumatic vertebral compression fracture seen on a lateral spinal radiograph Exclusion criteria: not specifically described |
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Interventions | 1. Calcitriol 0.5 μg daily in 2 doses by mouth
Randomised 314, completed 1 years 262, 2 years 236, 3 years 213 2. Elemental calcium 1 g daily (5.2 g calcium gluconate twice daily). Randomised 308, completed 1 years 253, 2 years 240, 3 years 219 Patients instructed not to take any other calcium supplement, but otherwise diet, and exercise programmes were unsupervised Duration of treatment 3 years |
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Outcomes | Measured at 1, 2, and 3 years 1. Number of women with new vertebral fractures 2. Number of fractures of the appendicular skeleton by the end of 3 years of treatment 3. Episodes of hypercalcaemia 4. Renal calculi 5. Number of persons dying 6. Gastro‐intestinal symptoms | |
Notes | Interim reports published in 1990 and 1991 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States "randomization codes", no other information provided |
Allocation concealment (selection bias) | Unclear risk | No details provided |