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

Coco 2003.

Methods
  • Study design: parallel RCT

  • Duration of study: 1 August 1999 to 30 November 2000

  • Duration of follow‐up: 3 years

Participants
  • Country: USA

  • Setting: single centre

  • Inclusion criteria: adult transplant recipients who were haemodynamically stable perioperatively

  • Number: treatment group (31); control group (28)

  • Mean age ± SD (years): treatment group (43.8 ± 2.3); control group (44.3 ± 2.3)

  • Sex (M/F): treatment group (12/19); control group (19/9)

  • Exclusion criteria: pregnancy; inability to return to follow up; participation in another study

Interventions Treatment group
  • Pamidronate (parenteral): 60 mg within 48 hours of transplantation followed by 30 mg at months 1, 2, 3 and 6


Control group
  • No treatment


Co‐interventions
  • Vitamin D or analogue

  • Oral calcium carbonate

Outcomes
  • Biochemical parameters including vitamin D, iPTH, serum osteocalcin, bone specific alkaline phosphatase, and urinary N‐telopeptide

  • Bone histomorphometry measured and calculated according to the American Society of Bone and Mineral Research

  • BMD of vertebral spine (L1 to L4) and hip by DEXA

  • Incidence of fracture at any site

  • Graft function

  • Mortality

Notes
  • Funding source: not reported

  • Trial registration: not applicable at trial published before end of 2005

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated number system
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk IV versus oral therapy. Unlikely to be blinded
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 out of 72 patients did not complete the study and their data were excluded from analysis
Selective reporting (reporting bias) High risk Did not report patient‐level outcomes including graft function or fracture. No protocol published before published trial was completed
Other bias High risk Imbalance in gender and time on dialysis between treatment groups