Letocha 2005.
Methods | Single centre, non blinded, RCT. No placebo control. Parallel trial. |
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Participants | 18 children were randomised.
Age range: 4 ‐ 13 years. OI type III and IV included. |
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Interventions | IV pamidronate versus control.
Dosage: 10 mg/m2/day for 3 days every 3 months.
Trial period: 12 months initially, then 7 participants in the treatment group were given an additional 6 ‐ 21 months of IV pamidronate.
Note: 4 children in each group were receiving recombinant growth hormone (rGH) (0.06 mg/kg/day for 6 days/week). All participants were seen quarterly at the National Institutes of Health Clinical Center. Serum markers of bone formation and growth parameters were measured at each visit. Antero‐posterior (AP) and lateral radiographs of the spine and lower extremity long bones and DXA at vertebrae L1–L4 were obtained at baseline and every 6 months. QCT scans of the spine were performed at the National Institutes of Health Clinical Center at 0 and 12 months. |
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Outcomes | L1 ‐ L4 DXA, spine QCT, spine radiographs, musculoskeletal and functional testing. | |
Notes | Allocation of intervention ‐ adequate. "Randomly‐generated numbers". | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly‐generated numbers. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Trial was stated as non‐blind but during measurements, the investigator was blinded to participant identifiers, the order of the films, and whether they came from the treatment or control groups. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | A per protocol and repeated‐measures model was used. It is not clear if all randomised participants completed the trial. |
Selective reporting (reporting bias) | High risk | Reported no significant change in biochemical markers of bone and mineral metabolism. |
Other bias | Low risk | None. |