Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 4

Conditions: Renal Osteodystrophy

Treatments: Drug: Zoledronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01675089

2011/22962-3 (Other Grant/Funding Number)

0776/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

34 participants in 2 patient groups

Zoledronic acid

Experimental group

Description:

Intravenous administration of zoledronic acid (5 mg) in a single dose at the time of kidney transplantation and vitamin D replacement.

Treatment:

Drug: Zoledronic acid

Control

No Intervention group

Description:

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.