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

Omidvar 2011.

Methods
  • Study design: active comparator, parallel RCT

  • Duration of study: not reported

  • Duration of follow‐up: 3 months

Participants
  • Country: Iran

  • Setting: single centre

  • Inclusion criteria: kidney transplant recipients > 20 years; T‐score < ‐2 (lumbar spine, femoral neck or total hip)

  • Number: treatment group (20); control group (20)

  • Mean age, range (years): treatment group (38.5, 20 to 57); control group (37.2, 20 to 58)

  • Sex (M/F): treatment group (13/7); control group (14/6)

  • Exclusion criteria: history of hyperthyroidism, hyperparathyroidism, hypocalcaemia, hypercalcaemia, fracture in the past 2 years; incapability to sit for > 30 minutes; active gastric ulcer; achalasia; scleroderma; any oesophageal abnormalities with delay in oesophageal emptying

Interventions Treatment group
  • Pamidronate (IV): 90 mg from the 3rd week post transplant


Control group
  • Alendronate (oral): 70 mg/week


Co‐interventions
  • Calcitriol

  • Calcium carbonate

Outcomes
  • Change in BMD in lumbar spine, femur +/‐ femoral neck at 6 months

  • Kidney function (eGFR)

  • Serum calcium

Notes
  • Funding source: grant from Ahvaz Jundishapur University of Medical Sciences

  • 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 High risk Comparing intravenous with oral medication. Although stated that investigators were blinded to treatment allocation, patients were unblinded and nature of interventions meant that blinding was unlikely.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All 40 patients completed study
Selective reporting (reporting bias) High risk Patient important outcomes were not all reported in systematic way
Other bias Low risk No additional threats to validity identified