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

Koc 2002.

Methods

  • Study design: no treatment‐controlled, parallel RCT

  • Duration of study: not reported

  • Duration of follow‐up: 12 months
Participants

  • Country: Turkey

  • Setting: single centre

  • Inclusion criteria: non‐diabetic kidney transplant recipients

  • Number: treatment group 1 (8); treatment group 2 (8); control group (8)

  • Mean age ± SD (years): treatment group 1 (34.4 ± 8.9); treatment group 2 (40.5 ± 8.1); control group (35.5 ± 8.4)

  • Sex (M/F): treatment group 1 (6/2); treatment group 2 (5/3); control group (6/2)

  • Time since transplant (months): treatment group 1 (48.7 ± 50.1); treatment group 2 (47.4 ± 46.4); control group (41.5 ± 37.1)

  • Exclusion criteria: duration of transplant < 12 months, SCr > 0.18 mmol/L or ≥ 20% increment during the preceding 12 months or prednisolone dosage that changed during the study period; hyperparathyroidism; gonadal insufficiency; parathyroidectomy or other cause of osteoporosis
Interventions Treatment group 1

  • Alendronate (oral): 5 mg/d


Treatment group 2

  • Calcitonin (intranasal): 100 µL alternate days, stopped 1 month of every 3 months


Control group

  • No treatment


Co‐interventions

  • Calcium carbonate, increased if hypocalcaemia. Participants did not receive fluoride, vitamin D, or any hormonal therapy
Outcomes

  • SCr, calcium and phosphorus

  • BMD by DEXA of lumbar vertebrae and femoral neck
Notes

  • Funding source: not reported

  • Trial registration: not applicable as study 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 Unblinded 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 11/24 participants were not included in final analysis
Selective reporting (reporting bias) High risk Patient‐centred outcomes not reported systematically
Other bias Low risk No additional threats to validity identified