Senthilnathan 2008.
Methods | Single‐centre, parallel, double blinded, RCT. | |
Participants | 12 randomised, 6 in each group. Number who received treatment and were analysed Low dose = 6 High dose = 4 Infants with OI who had long bone fractures with consequent deformity at birth or within the first 3 months of life, and/or multiple crush fractured vertebrae 7 males and 5 females under one year of age. |
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Interventions | 6 or 12 mg/kg/year of pamidronate by IV infusion. | |
Outcomes | Change in BMD as assessed by DEXA, Change in biochemical markers of bone and mineral metabolism (e.g., bone alkaline phosphatase measurements), growth. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Carers and participants blinded and outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One infant died from pneumonia 3 weeks after receiving the first infusion and one infant was withdrawn due to non attendance for scheduled infusions. Both were in the 12 mg/kg group (high dose). |
Selective reporting (reporting bias) | Low risk | Outcomes reported. |
Other bias | Unclear risk | Problems with accrual. |