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

Haas 2003.

Methods
  • Study design: placebo‐controlled, parallel RCT

  • Duration of study: not reported

  • Duration of follow‐up: 32 months

Participants
  • Country: Austria

  • Setting: multicentre (no of sites not reported)

  • Inclusion criteria: successful deceased donor, kidney transplantation of 1st or 2nd transplant; normocalcaemia, SCr < 0.18 mmol/L at 2 weeks; baseline bone biopsy demonstrates no adynamic bone disease

  • Number: treatment group (10); control group (10)

  • Mean age ± SE (years): treatment group (55 ± 18); control group (49 ± 16)

  • Sex (M/F): treatment group (6/4); control group (6/4)

  • Exclusion criteria: previous or current treatment with calcitonin or bisphosphonate or with hypocalcaemia

Interventions Treatment group
  • 1,25 dihydroxyvitamin D3 (oral): 0.25 µg/d


Control group
  • Placebo


Co‐interventions
  • Not reported

Outcomes
  • BMD by DEXA at lumbar spine (L1‐L4) and femoral neck

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

  • SCr

  • Incidence of acute graft rejection

Notes
  • Funding source: Research grant from Novartis

  • 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 Unclear risk Patients treated with intervention or placebo, but nature of placebo not fully described
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Bone biopsy histological analysis conducted by pathologist who was unaware of treatment allocation. Assessment of fracture not described
Incomplete outcome data (attrition bias) 
 All outcomes High risk Outcome data reported for 13/28 participants
Selective reporting (reporting bias) Low risk Patient‐centred outcomes reported
Other bias High risk Funded by Novartis