Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants

Renal Insufficiency Clinical Trial

Official title:

Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580047
• Other study ID #: 0437-02-FB
• Status: Completed
• Phase: N/A
• Start date: December 1, 2003
• Est. completion date: July 29, 2014

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.

Description:

The aims are to determine baseline bone mineral density (BMD) in kidney and kidney/pancreas transplant patients who will be randomized to weekly alendronate, annual zoledronic acid infusions or placebo (calcium with Vitamin D). These patients will be followed for two years with annual bone density testing as well as biochemical markers. A secondary aim is to evaluate the compliance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 29, 2014
• Est. primary completion date: July 29, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Transplant patients who have had a kidney or kidney/pancreas transplant in the last 150 days with adequate kidney function as defined by a calculated creatine clearance of 35ml/min or more and serum creatinine less than 3.0

Exclusion Criteria:

• Dual X-ray Absorptiometry (DXA) T-score at the spine or hip of -3 or lower

• History of more than one vertebral or non-vertebral fracture in the past two years

• Abnormalities of the esophagus which delay esophageal emptying

• Inability to stay upright for 30 minutes

• Pregnant, nursing women or women not using an effective form of birth control

• Hypocalcemia

• Hypercalcemia

• Calculated creatinine clearance of <35 ml/min or serum creatinine > 3.0

• Patients already treated with bisphosphonates within the past one year

• Patients unable to undergo DXA

• Patients with cancer

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• Zoledronic Acid
4mg IV Annually

Combination Product:
• Calcium with vitamin D
1200 mg Calcium with 800 International Units of vitamin D

Drug:
• Alendronate
70mg weekly

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (2)

Shane E, Cohen A, Stein EM, McMahon DJ, Zhang C, Young P, Pandit K, Staron RB, Verna EC, Brown R, Restaino S, Mancini D. Zoledronic acid versus alendronate for the prevention of bone loss after heart or liver transplantation. J Clin Endocrinol Metab. 2012 Dec;97(12):4481-90. doi: 10.1210/jc.2012-2804. Epub 2012 Sep 28. — View Citation

Wang J, Yao M, Xu JH, Shu B, Wang YJ, Cui XJ. Bisphosphonates for prevention of osteopenia in kidney-transplant recipients: a systematic review of randomized controlled trials. Osteoporos Int. 2016 May;27(5):1683-90. doi: 10.1007/s00198-015-3465-7. Epub 2016 Jan 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant	Posterior Anterior (PA) spine bone density was measured by dual energy x-ray absorptiometry (DXA) at baseline and 24 months post transplant. The percentage change in the PA spine bone density was then compared from baseline to 24 months post transplant.	24 months
Secondary	Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation	Compare compliance where a study coordinator interviewed patients as to how often they missed the once a week oral alendronate, missed taking calcium and vitamin D supplementation, or missed the once a year IV Reclast.	24 months