Clinical trial

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

Name
0437-02-FB
Description
The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.
Trial arms
Trial start
2003-12-01
Estimated PCD
2014-07-29
Trial end
2014-07-29
Status
Completed
Treatment
Zoledronic Acid
4mg IV Annually
Arms:
1 Zoledronic Acid
Other names:
Zometa
Calcium with vitamin D
1200 mg Calcium with 800 International Units of vitamin D
Arms:
3 Placebo
Other names:
calcium citrate, calcium carbonate
Alendronate
70mg weekly
Arms:
2 Alendronate
Other names:
Fosamax
Size
59
Primary endpoint
Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant
24 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 59, 'type': 'ACTUAL'}}
Updated at
2023-10-04

1 organization

3 products

1 indication