Barros 2012.
Methods | Parallel, open‐label RCT. | |
Participants | Children and adolescents with a diagnosis of OI (types I, III and IV) with a history of at least one minimal trauma fracture in the past year and no prior exposure to bisphosphonates. Age: 1 ‐ 15 years. 17 males and 6 females. Exclusion criteria not stated. |
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Interventions | PAM: < 3 years of age (1 mg/kg/day over 2 consecutive days every 3 months); > 3 years of age (1 mg/kg/day over 2 consecutive days every 4 months). ZOL: < 3 years of age (0.025 mg/kg/day over 2 consecutive days every 3 months); > 3 years of age (0.050 mg/kg/day over 2 consecutive days every 4 months). Treatment period: 1 year. |
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Outcomes | Height Weight Biochemistry BMD (lumbar spine and total body) BMC |
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Notes | Baseline characteristics differ between the groups. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Only stated as randomised. Baseline characteristics appear to differ between the groups 12 pieces of paper marked with treatment 1 and 12 pieces of paper marked with treatment 2 were put in a closed box. As the participants were seen and agreed to participate, one paper was drawn from the box to define which treatment the participant would receive, because of this, the age could not be paired. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) All outcomes | High risk | Open label. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information given. |
Selective reporting (reporting bias) | Unclear risk | Decreased fracture rate not reported completely, but no indication if this is due to the results. |
Other bias | Low risk | None. |