Reid 2005.
Study characteristics | ||
Methods | Double‐blind, randomised, controlled trial The trial was conducted in New Zealand. |
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Participants | Healthy postmenopausal women more than 5 years from postmenopause Age: more than 55 years (mean age, 74 years) Mean baseline weight: 67 kg Mean baseline blood pressure:134/70 mmHg Exclusion criteria: participants receiving therapy for osteoporosis or taking calcium supplements, major ongoing disease including serum creatinine greater than 1.8 mg/dL (0.2 mmol/litre), untreated hypo‐ or hyperthyroidism, liver disease, serum 25‐hydroxyvitamin D below 10 g/litre (25 nmol/litre), malignancy, or metabolic bone disease, users of hormone replacement therapy, anabolic steroids, glucocorticoids, or bisphosphonate in the previous 1 year |
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Interventions | Intervention group: calcium as calcium citrate (1 gm of elemental calcium a day; n = 732) Control group: identical placebo (n = 739) Trial duration 30 months |
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Outcomes | Primary outcome: fracture incidence Secondary analysis: ‐ Body weight ‐ Blood pressure |
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Notes | Dietary calcium intake was assessed using a validated food frequency questionnaire. Calcium was provided by Citracal, Mission Pharmacal, San Antonio TX. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Treatments were allocated randomly using a minimisation algorithm balancing for current thiazide use, age, and the occurrence of fractures resulting from minimal trauma after the age of 40 years". |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded study. "Subjects received 1 g elemental calcium daily as citrate (Citracal, Mission Pharmacal, San Antonio TX) or an identical placebo". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Blood pressure was measured using a Dinamap automatic monitor (Johnson & Johnson, Tampa, FL) at each visit". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropouts were not reported. |
Selective reporting (reporting bias) | Low risk | A variety of preplanned models were run: an intention‐to‐treat analysis, with and without imputation (maximum likelihood) of missing values, and with and without adjustment for compliance; a per protocol analysis; and an analysis of the change in blood pressure, excluding those taking blood pressure‐lowering medication. |
Other bias | Low risk | Baseline characteristics were similar between groups. |