The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.
Full Title of Study: “Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplant”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 2014
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.
- 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
Arms, Groups and Cohorts
- Active Comparator: 1
- Zoledronic Acid 4mg intravenously once a year for 2 years
- Active Comparator: 2
- Alendronate 70mg orally once a week for 2 years
- Placebo Comparator: 3
- Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily
Clinical Trial Outcome Measures
- Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant
- Time Frame: 24 months
- Percentage Change in Posterior Anterior (PA) spine bone density from baseline to 24 months post transplant
- Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation
- Time Frame: 24 months
- 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.
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 19 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Nebraska
- Provider of Information About this Clinical Study
- Principal Investigator: Lynn Mack, MD, Associate Professor – University of Nebraska
- Overall Official(s)
- Lynn Mack, MD, Principal Investigator, University of Nebraska
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. Review.
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.
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