Clinical trial NCT00580047: Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants
Official title: Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency
Keywords: bone density
osteopenia
transplant
zoledronic acid
alendronate
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 59
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant
timeFrame: 24 months
Secondary outcomes:
measure: Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation
timeFrame: 24 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Lynn Mack, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.