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. 2019 Oct 22;2019(10):CD005015. doi: 10.1002/14651858.CD005015.pub4

Coco 2012.

Methods
  • Study design: parallel RCT

  • Duration of study: 2002 to 2006

  • Duration of follow‐up: 12 months

Participants
  • Country: USA

  • Setting: single centre

  • Inclusion criteria: adult kidney transplant recipients

  • Number: treatment group (20); control group (22)

  • Mean age ± SD (years): treatment group (42 ± 11); control group (48 ± 14)

  • Sex (M/F): treatment group (11/9); control group (16/6)

  • Exclusion criteria: inability to return for regular follow‐up; participation in another study

Interventions Treatment group
  • Risedronate (oral): 35 mg weekly starting once SCr < 177 μmol/L


Control group
  • Placebo


Co‐interventions
  • Calcitriol: 0.25 μg daily

Outcomes
  • Change in BMD of lumbar spine, total hip and distal radius

  • Bone fracture at any site

  • Biomarkers of bone turnover

  • Bone histomorphometry on bone biopsy

Notes
  • Funding source: quote "This study was supported by grants from the Kidney and Urology Foundation of America and the Institute for Clinical and Translational Research of Albert Einstein College of Medicine."

  • Trial registration: NCT00266708

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated sequence
Allocation concealment (selection bias) Unclear risk Randomisation was done by pharmacist using computer‐generated randomisation. Reported in insufficient detail to perform adjudication
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Identical placebo achieved by over encapsulation of the risedronate capsules to appear similar to the placebo
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk 13/42 participants were not included in entire follow up for reasons that may have been related to outcome
Selective reporting (reporting bias) High risk Patient‐centred outcomes were not systematically evaluated or reported
Other bias Low risk Study appears free of other biases