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. 2016 Oct 19;2016(10):CD005088. doi: 10.1002/14651858.CD005088.pub4

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