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

Torregrosa 2010.

Methods

  • Study design: open‐label, parallel RCT

  • Duration of study: not reported

  • Duration of follow‐up: 12 months
Participants

  • Country: Spain

  • Setting: multicentre (11 sites)

  • Inclusion criteria: kidney transplant recipients between 18 and 75 years

  • Number: treatment group (52); control group (49)

  • Mean age ± SD (years): treatment group (47.4 ± 14.1); control group (50.7 ± 15.5)

  • Sex (M/F): treatment group (28/15); control group (27/11)

  • Exclusion criteria: highly immunised patients (> 75% PRA); multiple organ transplantation; insulin‐dependent DM at the time of transplantation; parathyroidectomy; treatment with fluorine, bisphosphonate, or substitutive hormones (oestrogen, selective modulators of the estrogenic recipients) within the past 6 months; treatment with anticonvulsants or calcitonin within the past 3 months; hypersensitivity to bisphosphonate; dyspepsia or gastroesophageal reflux at baseline; severe gastric or oesophageal disease; pregnant or breastfeeding women; unable to stand up; immunosuppressant therapy other than tacrolimus and steroids; included in other trials
Interventions Treatment group

  • Risedronate (oral): 35 mg/week


Control group

  • No treatment


Co‐interventions

  • Calcium carbonate: 1500 mg/d

  • Vitamin D3: 400 IU/d
Outcomes

  • Change in BMD at lumbar spine at 12 months

  • Change in serum calcium, phosphate, alkaline phosphatase, vitamin D, iPTH

  • kidney function (creatinine)
Notes

  • Funding source: Astellas Pharma, SA

  • Trial registration: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Unclear risk Done using sealed envelopes. Unclear whether the envelopes were sequentially numbered and opaque
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Assessment of radiographs Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk 15/101 patients did not complete study
Selective reporting (reporting bias) High risk Patient‐centred outcomes not fully reported
Other bias High risk Funded by Astellas Pharma