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

Cueto‐Manzano 2000.

Methods
  • Study design: parallel RCT

  • Duration of study: May to December 1996

  • Duration of follow‐up: 12 months

Participants
  • Country: UK

  • Setting: single centre

  • Inclusion criteria: 1st kidney transplant > 2 years previously, stable graft function

  • Number: treatment group (16); control group (14)

  • Mean age ± SD (years): treatment group (51.7 ± 11.9); control group (44.3 ± 9.4)

  • Sex (M/F): treatment group (11/5); control group (5/9)

    • Postmenopausal: treatment group (4; 25%); control group (4; 29%)

  • Exclusion criteria: previous vertebral or hip fracture; prolonged immobilisation; systemic illness or malignancy; intake of oestrogens or drugs affecting bone metabolism

Interventions Treatment group
  • Calcium carbonate: 500 mg for 12 months

  • 1,25 dihydroxyvitamin D3 (oral): 0.25 µg for 12 months


Control group
  • No treatment

Outcomes
  • Serum calcium, phosphate, SCr

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

Notes
  • Funding source: not reported

  • Trial registration: not applicable as published before the end of 2015

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 15/45 patients were not included in full study follow up
Selective reporting (reporting bias) High risk Patient‐level outcomes were not systematically captured
Other bias Low risk Study appears free of other biases