Trial record 11 of 378 for:
Open Studies | kidney transplantation
Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation
This study is currently recruiting participants.
Verified March 2013 by University of Sao Paulo General Hospital
Sponsor:
University of Sao Paulo General Hospital
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01675089
First received: August 23, 2012
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Osteodystrophy |
Drug: Zoledronic acid |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective and Randomized Trial of Zoledronic Acid to Prevent Bone Loss in the First Year After Kidney Transplantation |
Resource links provided by NLM:
Further study details as provided by University of Sao Paulo General Hospital:
Primary Outcome Measures:
- Differences in bone turnover [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Bone histomorphometric data will be analyzed at baseline and after 1 year of kidney transplantation.
Secondary Outcome Measures:
- Bone microarchitecture [ Time Frame: 1 year ] [ Designated as safety issue: No ]Bone microarchitecture will be examined by high-resolution peripheral quantitative computed tomography at the time of transplant and after 12 months.
- Changes in Bone Mineral Density [ Time Frame: 1 year ] [ Designated as safety issue: No ]Bone mineral density (BMD) measurements by dual-energy X-ray absorptiometry (DEXA) will be made at the time of transplant and after 6 and 12 months.
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Zoledronic acid
Intravenous administration of zoledronic acid (5 mg) in a single dose at the time of kidney transplantation and vitamin D replacement.
|
Drug: Zoledronic acid
The treatment group will receive 15-minute intravenous administration of zoledronic acid (5 mg) in a single dose at the time of kidney transplantation and vitamin D replacement. The aim of vitamin D replacement will be serum levels of 25 (OH) vitamin D above 30 ng/ml.
Other Name: Aclasta
|
|
No Intervention: Control
The control group will receive only vitamin D replacement. The aim of vitamin D replacement will be serum levels of 25 (OH) vitamin D above 30 ng/ml.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675089
Contacts
| Contact: Elias David-Neto, PhD | +55 11 2661 8089 | elias.david.neto@attglobal.net |
| Contact: Igor Marques, MD | +55 11 2661 8089 | igordenizarde@yahoo.com.br |
Locations
| Brazil | |
| Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo | Recruiting |
| Sao Paulo, Brazil, 05403-900 | |
| Contact: Elias David-Neto, MD +55 - 11 - 2661-8089 elias.david.neto@attglobal.net | |
| Principal Investigator: Elias David-Neto, MD | |
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
| Principal Investigator: | Elias David-Neto, MD | University of Sao Paulo |
More Information
No publications provided
| Responsible Party: | University of Sao Paulo General Hospital |
| ClinicalTrials.gov Identifier: | NCT01675089 History of Changes |
| Other Study ID Numbers: | 0776/11, 2011/22962-3 |
| Study First Received: | August 23, 2012 |
| Last Updated: | March 11, 2013 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo General Hospital:
|
bone disease kidney transplantation bisphosphonates |
Additional relevant MeSH terms:
|
Renal Osteodystrophy Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Rickets Kidney Diseases Urologic Diseases Calcium Metabolism Disorders Metabolic Diseases Vitamin D Deficiency Avitaminosis Deficiency Diseases |
Malnutrition Nutrition Disorders Hyperparathyroidism, Secondary Hyperparathyroidism Parathyroid Diseases Endocrine System Diseases Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013