Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation
Information source: University of Sao Paulo General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Osteodystrophy
Intervention: Zoledronic acid (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Sao Paulo General Hospital Official(s) and/or principal investigator(s): Elias David-Neto, MD, Principal Investigator, Affiliation: University of Sao Paulo
Summary
The purpose of this study is to determine whether zolendronic acid, a third generation
bisphosphonate, is effective in preventing bone loss in the first year after kidney
transplantation.
Clinical Details
Official title: A Prospective and Randomized Trial of Zoledronic Acid to Prevent Bone Loss in the First Year After Kidney Transplantation
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Differences in bone turnover
Secondary outcome: Bone microarchitectureChanges in Bone Mineral Density
Detailed description:
For the treatment of osteoporosis in the general population, a number of drugs reduce BMD
(bone mineral density) loss and the rate of incident fractures. For instance,
bisphosphonates improve BMD, reduce hip fracture rates and decrease mortality in
post-menopausal women. Because of lack of data on safety and an increased risk of adverse
effects, the use of these drugs is controversial in patients with chronic kidney disease
(CKD) and abnormalities of PTH or vitamin D, an estimated glomerular filtration rate (GFR)
less than 30 ml/min/1. 73m² (CKD stages 4 and 5) and after transplantation. The efficacy of
short and long term bisphosphonate treatment after kidney transplantation has been examined;
however, histomorphometric and fracture rate reduction data are lacking.
The purpose of this study is to determine whether zolendronic acid, a third generation
bisphosphonate, is effective in preventing bone loss in the first year after kidney
transplantation.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All adult kidney transplant recipients who were stable perioperative and able to
return for regular follow-up
Exclusion Criteria:
- Glomerular filtration rate < 30 ml/min/1. 73m² one week after transplantation
- Previous parathyroidectomy or diagnosis of adynamic bone disease (with bone biopsy)
Locations and Contacts
Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo, Sao Paulo 05403-900, Brazil
Additional Information
Starting date: July 2012
Last updated: May 16, 2014
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