Bishop 2010.
Methods | Multicentre, parallel, double‐blinded RCT dose‐ranging trial of risedronate. | |
Participants | 53 children randomised and 48 received treatment 0.2 mg/kg/wk = 17 1 mg/kg/wk = 18 2 mg/kg/wk = 18 Mean age 0.2 mg/kg/wk = 10.8 (3.8 ‐ 17) years 1 mg/kg/wk = 10.8 (5.2 ‐ 16.5) years 2 mg/kg/wk = 11 (5.8 ‐ 17) years Sex of participants (M/F) 0.2 mg/kg/wk = 6/11 1 mg/kg/wk = 8/10 2 mg/kg/wk = 4/14 OI type (I, III, IV) 0.2 mg/kg/wk = 0/4/13 1 mg/kg/wk = 0/2/16 2 mg/kg/wk = 1/1/16 |
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Interventions | Children were randomised to receive 0.2 mg, 1 mg or 2 mg/kg/week risedronate for 2 years, dose prescribed to the nearest 5 mg. Oral doses administered were multiples of the same tablet of sizes 2.5, 5, 15, 30 or 35 mg; for instance a child weighing 50 kg randomised to 2 mg/kg/week would receive 3 x 35 mg i.e. 105 mg. | |
Outcomes | Fracture reduction as assessed by skeletal survey Change in BMD Change in biochemical markers of bone/mineral metabolism Growth Bone pain/functional outcome Pediatric evaluation of disability inventory (PEDI) Gros motor function measure (GMFM) Grip strength at trial initiation vs 24 months |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was by multiple permuted blocks, stratified according to age (up to 10.99 years, or above) allocated by a remote telephone system. |
Allocation concealment (selection bias) | Low risk | Allocation was by a remote telephone system. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Children, their families and medical staff were blinded to the treatment assignment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 participants withdrew during the 2‐year period of the trial and were lost to follow up. 1 child did not like the taste of the tablets, 1 developed an inflammatory bowel condition thought not to be related to the medication, 3 withdrew without giving a reason. The 5 children were distributed between groups 1/2/2. Consort diagram shown. |
Selective reporting (reporting bias) | High risk | Bishop states that there was no difference between the groups in pain scores but no data was presented. For quality of life, data was not presented separately by treatment group. |
Other bias | Low risk | None |