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

Walsh 2009.

Methods
  • Study design: open‐label, parallel RCT

  • Duration of study: May 2001 to December 2003

  • Duration of follow‐up: 24 months

Participants
  • Country: UK

  • Setting: multicentre (7 sites)

  • Inclusion criteria: kidney transplant recipients

  • Number: treatment group (46); control group (47)

  • Mean age ± SD (years): treatment group (46.1 ± 12.8); control group (46.1 ± 12.9)

  • Sex (M/F): treatment group (35/11); control group (34/13)

  • Exclusion criteria: PTH < 150 pg/mL

Interventions Treatment group
  • Pamidronate: 1 mg/kg IV perioperatively, then at 1, 4, 8, and 12 months post transplant


Control group
  • No treatment


Co‐interventions
  • Calcium: 500 mg/d

  • Vitamin D3: 400 IU/d

Outcomes
  • Change in BMD at lumbar spine by 12 months

  • Incidence of fractures

  • Change in serum calcium, phosphate, PTH, and vitamin D

  • Biomarkers of bone turnover

  • Acute rejection

  • Kidney function (creatinine)

  • Adverse events of medications

Notes
  • Funding source: Novartis

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Statistical Analysis System (SAS Institute, Cary, NC)–based randomization macro; randomization was stratified for sex and baseline PTH level"
Allocation concealment (selection bias) Low risk Quote: "Four‐digit randomization numbers were allocated to patients through a telephone randomization process"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Unblinded comparing intravenous therapy with no treatment control
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Observers blinded to treatment allocation assessed radiographs individually then conferred with 2nd observed
Incomplete outcome data (attrition bias) 
 All outcomes High risk 125 randomly assigned to treatment; 32 randomised participants were excluded (19 in treatment group and 13 in control group)
Selective reporting (reporting bias) Low risk Patient‐centred outcomes captured and reported
Other bias High risk Funded by Novartis; one author employee of Novartis