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

Jeffery 2003.

Methods
  • Setting: active comparator, parallel RCT

  • Duration of study: November 1997

  • Duration of follow‐up: 12 months

Participants
  • Country: Canada

  • Setting: multicentre (2 sites)

  • Inclusion criteria: kidney transplant recipients, stable kidney function, estimated GFR > 35 mL/min, T‐score < ‐1 at either lumbar spine or femur

  • Number: treatment group (57); control group (60)

  • Mean age at transplantation ± SD (years): treatment group (44.8 ± 11.6); control group (45.9 ± 10.8)

  • Mean time since transplantation ± SD (years): treatment group (7.1 ± 5.2); control group (9.6 ± 6.8)

  • Sex (M/F): treatment group (34/12); control group (37/14)

  • Exclusion criteria: previous treatment for bone disease, recent oesophagitis or gastritis

Interventions Treatment group
  • Alendronate (oral): 10 mg/d


Control group
  • Calcitriol (oral): 0.25 µg/d


Co‐interventions
  • Not reported

Outcomes
  • BMD by DEXA at lumbar vertebrae (L2‐L4) and proximal femur

  • SCr

Notes
  • Funding source: not reported

  • Trial registration: not applicable as published before end of 2005

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk 20/117 participants did not complete study
Selective reporting (reporting bias) High risk Patient‐centred outcomes not reported systematically
Other bias High risk Imbalanced time since transplantation between groups at baseline