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

Grotz 1998.

Methods

  • Study design: parallel RCT

  • Duration of study: 1974 to 1993

  • Duration of follow‐up: 12 months
Participants

  • Country: Germany

  • Setting: single centre

  • Inclusion criteria: kidney allograft recipients, greater than 6 months post transplant; BMD below ‐1.5 SD

  • Number: treatment group 1 (16); treatment group 2 (15); control group (15)

  • Mean age ± SD (years): treatment group 1 (45 ± 12); treatment group 2 (41 ± 12); control group (48 ± 12)

  • Sex (M/F): treatment group 1 (7/9); treatment group 2 (10/5); control group (12/3)

  • Post‐menopausal: treatment group (6/9); treatment group 2 (2/5); control group (0/3)

  • Time after transplantation (months): treatment group (54 ± 47); treatment group 2 (44 ± 30); control group (72 ± 59)

  • Exclusion criteria: not reported
Interventions Treatment group 1

  • Clodronate: 800 mg/d


Treatment group 2

  • Calcitonin (intranasal): 100 IU/d BD for 14 days followed by 75 days without treatment


Control group

  • No treatment


Co‐interventions

  • Calcium
Outcomes

  • SCr, calcium, phosphorus

  • BMD by DEXA of lumbar spine (L1‐4)

  • Radiography of lumbar spine where vertebral fracture is defined as reduction of central or anterior vertebral body height greater than 15% of the posterior vertebral height
Notes

  • Funding source: not reported

  • Trial registration: not applicable as 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 Allocation using sealed envelopes. Not described as sequentially numbered.
Blinding of participants and personnel (performance bias) 
 All outcomes High 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 Unclear risk 1/46 patients did not complete the study
Selective reporting (reporting bias) High risk Kidney transplant outcomes not reported systematically
Other bias High risk Imbalanced gender and menopausal status between groups at baseline