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

Ward 2010.

Methods Multicentre, parallel, double‐blinded placebo‐controlled RCT.
Participants 139 randomised
4 ‐ 19 years (ALN 11.0 (3.6) years; placebo 11.1 (4.0) years
78 males
61 females
Children and adolescents with a diagnosis of OI types III or IV or a diagnosis of OR type I associated with 1 or more of the following: chronic pain; more than 3 fractures (including vertebrae) per year with minimal trauma for the previous 2 years; or limb deformity requiring surgery.
Interventions ALN or placebo for 24 months
(< 40 kg) 5 mg daily
(> 40 kg) 10 mg daily
Placebo = 30
ALN = 109
Analysed: ALN = 83; placebo = 26
Outcomes Fracture reduction
Change in BMD as assessed by DEXA
Change in biochemical markers of bone and mineral metabolism
Growth
Bone pain
PEDI score
Grip strength
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomized in a 3:1 ratio and stratified according to their weight at baseline.
Allocation concealment (selection bias) Unclear risk Not stated.
Blinding (performance bias and detection bias) 
 All outcomes Low risk double blind. outcome assessors blind.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Total = 30, ALN = 26, Placebo = 4. Reasons given per group in figure 1 – consort diagram. Modified ITT.
Selective reporting (reporting bias) Low risk Outcomes reported.
Other bias Low risk None.