DiMeglio 2006.
Methods | Single centre, unblinded RCT. Parallel trial. |
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Participants | 18 children (7 males) were randomised. Mean age: 8.7 years. Oral arm mean: 9 years (range 3.8 ‐ 12.7 years); IV arm mean: 8.4 years (3 ‐ 13.7 years). OI types I, III, IV included. | |
Interventions | IV pamidronate disodium 1 mg/kg/day every 4 months compared to oral alendronate 1 mg/kg daily.
Pamidronate diluted in 250 or 500 ml of normal saline given by slow infusion over 4 hours. Alendronate was given as 1 or 2 10 mg tablets, rounded to the nearest 10 mg dose for weight.
Trial period: 24 months. BMD, BMC, and area at the spine (L2–L4) and total body were measured every 4 months by DXA. |
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Outcomes | BMC, BMD, posteroanterior radiographs of left hand and wrist, radiographs of suspected fractures, blood and urine samples. | |
Notes | Allocation of intervention ‐ adequate. Computer random number generator. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A statistician created a randomisation schedule with a computer random number generator using a block‐randomisation scheme. Participants were stratified according to clinical severity of OI, pubertal stage, and bone age. |
Allocation concealment (selection bias) | Low risk | Random number sequences were concealed until the principal investigator assigned a group according to the stratification scheme. A nurse then consulted the randomisation schedule and determined whether the participant would receive oral or IV treatment. |
Blinding (performance bias and detection bias) All outcomes | High risk | Open label. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The type of analysis performed is not stated for the DiMeglio trial, although changes in group assignment were made when participants had difficulty tolerating the assigned regimen. One child on oral alendronate was lost to follow up after 8 months and is therefore not included in this analysis. |
Selective reporting (reporting bias) | High risk | Height was partially reported as graphs with groups combined as there was no statistically significant difference between groups. Bone pain was also not reported although not stated as measured. |
Other bias | Low risk | None. |