Bishop 2013.
Methods | Parallel, double‐blind RCT. | |
Participants | Children and adolescents with a diagnosis of OI (types not stated) with a history of at least 1 non‐traumatic/low‐impact fracture and BMD z score of ‐1.0 or less for total body or LS OR a real BMD z score of ‐2.0 or less regardless of fracture history. Those considered ineligible weighed less than 10kg, had cancer or untreated rickets, had low vitamin D or prior treatments which might have affected the results or disease severe enough they would have normally been given treatment anyway. 4 ‐ 15 years 71 females 72 males |
|
Interventions | 94 risedronate 49 placebo (10 kg ‐ 30 kg) 2.5 mg daily (> 30 kg) 5 mg daily |
|
Outcomes | Primary: % change from baseline lumbar spine BMD Secondary: % change from baseline in total body BMD at Month 12 % change from baseline in lumbar spine BMC at month 12 % change from baseline in total body BMC at month 12 Lumbar spine z score ‐ % change from baseline to month 12 Total body z score ‐ % change from baseline to month 12 % change from baseline in lumbar spine bone area at month 12 % change from baseline in total body bone area month 12 New morphometric vertebral fracture at month 12 Categorization by number of new morphometric vertebral fracture at month 12 Probability of fracture in 12 months Number of clinical fractures, month 12 Serum BAP ‐ % change from baseline to month 12 Urine NTX/Cr ‐ % change from baseline at month 12 Wong‐Baker FACES Pain Rating Scale ‐ change from baseline to month 12 Bone Age (years), change from baseline to month 12 Annualized growth velocity ‐ change from baseline to month 12 |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized in a 2:1 ratio by a telephone based interactive voice response system |
Allocation concealment (selection bias) | Low risk | Telephone based interactive voice response system |
Blinding (performance bias and detection bias) All outcomes | Low risk | The trial treatment was masked from participants, investigators, and trial centre personnel during the first year. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 7 participants discontinued in the intervention arm and reasons were provided. An ITT analysis was undertaken. |
Selective reporting (reporting bias) | Low risk | All outcomes are reported. |
Other bias | Low risk | None |