Roux 1995.
Study characteristics | ||
Methods | Trial design: single‐site, double‐masked, randomised, placebo‐controlled, dose‐ranging trial | |
Participants | Participants: 42 women were randomised; 40 women were analysed. Mean age: 34.0 ± 6.5 years (range 20‐44 years) Inclusion criteria:
Exclusion criteria:
Setting: France Timing: not stated |
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Interventions | All participants received triptorelin 3.75 mg IM every four weeks + norgestrel acetate 5 mg/day during the first 3 weeks following injection and then 1 g calcium carbonate daily for 27 weeks. In addition: Group 0: placebo intranasal spray, Group 1: salmon calcitonin 100 IU IN daily, Group 2: salmon calcitonin 200 IU IN daily. |
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Outcomes |
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Notes | Intention‐to‐treat analysis: yes Sample size calculation: yes Funding: not stated Author could not be contacted due to lack of information. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly devided". No further details of method used to generate the randomisation sequence were provided. |
Allocation concealment (selection bias) | Unclear risk | No details of method used to conceal allocation were provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, placebo‐controlled study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind, placebo‐controlled study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 participants failed to complete the study ‐ one was lost to follow‐up and one was excluded due to orthopaedic material in the lumbar spine. |
Selective reporting (reporting bias) | Low risk | The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were prespecified. |
Other bias | Low risk | No other risk of bias detected |