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

Sanchez‐Escuredo 2015.

Methods
  • Study design: open‐label, parallel RCT

  • Duration of study: 2009 to 2011

  • Duration of follow‐up: 12 months

Participants
  • Country: Spain

  • Setting: single centre

  • Inclusion criteria: kidney transplant recipients aged 50 to 75 years; kidney function with CrCl > 30 mL/min/1.73 m2; at least 12 months post transplant; iPTH > 60 pg/mL; T‐score < ‐1

  • Number: treatment group (35); control group (34)

  • Mean age ± SD (years): treatment group (63 ± 12); control group (64 ± 10)

  • Sex (M/F): treatment group (7/28); control group (4/30)

  • Exclusion criteria: DM; primary hyperthyroidism

Interventions Treatment group
  • Ibandronate (oral): 150 mg/month


Control group
  • Risedronate (oral): 35 mg/week


Co‐interventions
  • Calcium carbonate: 2500 mg/d

  • Vitamin D3: 800 IU/d

Outcomes
  • Change in serum calcium, iPTH, and alkaline phosphatase

  • Kidney function (eGFR)

  • Change in BMD at lumbar spine and femoral neck

Notes
  • Funding source: not reported

  • Trial registration: not reported

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 Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk 8/69 patients did not complete the study due to treatment‐related side effects
Selective reporting (reporting bias) High risk Patient important outcomes not captured or reported systematically
Other bias Low risk Study appears free of other biases