Ones 2007.
Study characteristics | ||
Methods | Randomised, open, controlled clinical trial Blinding of outcome assessors not reported 98 of 98 in groups reported here completed |
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Participants | Postmenopausal women with osteoporosis, country unclear (possibly Turkey or Switzerland) 98 postmenopausal women for trial arms used in this review, mean age 58 years Inclusion criteria: aged 50 to 70 years, postmenopausal for at least 5 years, lumbar or femoral BMD T‐score < ‐2.5 Exclusion criteria: secondary osteoporosis, other bone diseases, significant concomitant disease, abnormal liver or renal function, hypercalcaemia, hypercalciuria, major gastrointestinal diseases, e.g. peptic ulcer, drugs influencing bone metabolism (oestrogens, progestagens, selective oestrogen receptor modifiers, calcitonin, bisphosphonate, vitamin D and calcium, glucocorticoids) |
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Interventions | 1. 10 mg alendronate, 0.5 μg alfacalcidol, 500 mg calcium daily 2. 10 mg alendronate, 500 mg calcium daily 3. 0.5 μg alfacalcidol, 500 mg calcium daily ‐ used in this review 4. 500 mg calcium daily ‐ used in this review Randomisation said to be in ratio 1.5:2:1.5:1 Randomised 68/30, completed 68/30 Duration of treatment 2 years |
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Outcomes | Measured over a follow‐up of 2 years
1. Number of persons with new vertebral fracture 2. Number of persons with gastrointestinal effects |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | States "computer‐generated random lists)" |
Allocation concealment (selection bias) | Unclear risk | States "randomized"; no other information provided |