Rauch 2009.
Methods | Single centre, placebo‐controlled RCT. Parallel trial. |
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Participants | Risedronate: 13 Placebo: 13 Mean age (SD): 11.9 (4) years placebo, 11.7 (3.6) years risedronate 15 male, 11 female OI types I |
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Interventions | Risedronate (or placebo) 15 mg once per week if < 40 kg 30 mg once per week if > 40 kg |
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Outcomes | Every 3 months for bone pain, grip force, blood and urine tests and anthropometric measurements Every 12 months for bone age, radiographs of spine, BMD by DXA Baseline and 24 months for radiographs of long bones (or whenever a fracture sustained) Bone biopsy at 24 months |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomised in equal number to receive either risedronate or placebo. Both risedronate and placebo pills were provided by the manufacturer." |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Risedronate: 2 withdrew (lack of effect, refused to take pills) Placebo: 1 withdrew (lack of effect). |
Selective reporting (reporting bias) | High risk | Bone age stated as measured but not reported and grip strength was reported as not significant. Authors have been contacted for data. |
Other bias | Low risk | None. |