Peritoneal Dialysis | Alendronate for Vascular Calcification in Peritoneal Dialysis Patients?
Peritoneal Dialysis research study
What is the primary objective of this study?
Hyperphosphatemia is frequently seen in patients with end-stage renal disease (ESRD). Hyperphosphatemia usually results in a high calcium-phosphorus product (CPP) which may subsequently lead to artery and become a risk factor of cardiovascular complications. Alendronate, due to its effect of inhibiting osteoclasts, is approved for treatment of osteoporosis. Previous reports found the use of bisphosphonates could suppress arterial calcification in hemodialysis dialysis patients. The aim of this study is to evaluate the safety and efficacy of alendronate to suppress coronary artery and aortic calcifications, as well as to improve bone density in chronic peritoneal dialysis (PD) patients. This study will include ESRD patients who had received maintenance PD for more than 3 months, have high CPP level (≧55), and have chest X-ray proven aortic calcification or coronary artery calcification. All participants are randomly allocated to either group 1 or group 2. Group 1 patients receive alendronate 70 mg once weekly in the first 16 weeks, while group 2 patients receive the same dose of drug every week in the second 16 weeks. The extent of coronary artery and aortic calcification is evaluated by using multi-detector spiral computed tomography, whereas bone mineral density is measured by dual-energy X-ray absorptiometry. Both examinations are performed at week 0, 16 and 32 for each participant. Laboratory studies and possible adverse reactions were regularly monitored. We expect that alendronate can alleviate the progression of arterial calcification or even improve it. Bone density may also be improved after treatment. Besides, we wish to find the independent factor(s) influencing the efficacy of alendronate. These results may help clinical physicians for early intervention and prevention of cardiovascular complications in ESRD patients.
Who is eligible to participate?
Inclusion Criteria: - receive maintenance peritoneal dialysis for more than 3 months - have high calcium-phosphate product (>55 (mg/dL)2) - have chest X-ray proven aortic calcification or coronary artery calcification proven by coronary angiography Exclusion Criteria: - had been hospitalized in recent 3 months due to severe comorbid disease - hypersensitive to alendronate or any of its components - have esophageal disease - not able to stand or sit upright for 30 minutes - have refractory hypocalcemia - being pregnant
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: March 2006
Completed Date: December 2006
Phase: Phase 4
Primary Outcome: 1.Changes of calcification score of coronary arteries and aorta
Secondary Outcome: changes of parathyroid hormone
Study sponsors, principal investigator, and references
Principal Investigator: Chun-Fu Lai, M.D.
Lead Sponsor: Far Eastern Memorial Hospital