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

Trabulus 2008.

Methods
  • Study design: open‐label, active‐comparator, parallel RCT

  • Duration of study: January 2002 to June 2002

  • Duration of follow‐up: 12 months

Participants
  • Country: Turkey

  • Setting: single centre

  • Inclusion criteria: kidney transplant recipients with stable kidney function (SCr < 124 µmol/L)

  • Number: treatment group 1 (21); treatment group 2 (12); treatment group 3 (17)

  • Mean age ± SD (years): treatment group 1 (33.9 ± 10.3); treatment group 2 (32.5 ± 13.4); treatment group 3 (35.2 ± 7.7)

  • Sex (M/F): treatment group 1 (13/8); treatment group 2 (6/6); treatment group 3 (131/4)

  • Exclusion criteria: postmenopausal women; treatment with oestrogen, secondary osteoporosis due to type I or II DM, hyperthyroidism, primary or tertiary hyperparathyroidism; hypogonadism; hyperprolactinaemia; Cushing’s syndrome; acromegaly; chronic diarrhoea or malabsorption syndromes; history of GI illness (oesophagitis, peptic ulcer disease, or severe dyspepsia)

Interventions Treatment group 1
  • Alfacalcidol (oral): 0.5 µg/d


Treatment group 2
  • Alendronate (oral): 10 mg/d


Treatment group 3
  • Alendronate (oral): 10 mg/d

  • Alfacalcidol (oral): 0.5 µg/d


Co‐interventions
  • Calcium (oral): 1000 mg/d

Outcomes
  • Change in BMD at lumbar spine

  • Change in serum calcium, phosphate, iPTH, urine calcium

  • Biomarkers of bone turnover**

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) High risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Unblinded allocation to different medication strategies
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk 14/64 patients did not complete treatment for reasons that related to medication adverse effects
Selective reporting (reporting bias) High risk Patient‐centred outcomes not captured or reported systematically
Other bias High risk Imbalanced duration of kidney disease among treatment groups at baseline