Peritoneal Dialysis Clinical Trial
Official title:
Can Alendronate Suppress Aortic and Coronary Artery Calcification and Improve Bone Mineral Density in Chronic Peritoneal Dialysis Patients?
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Far Eastern Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Far Eastern Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1.Changes of calcification score of coronary arteries and aorta | |||
Primary | 2.Changes of bone density | |||
Secondary | changes of parathyroid hormone | |||
Secondary | changes of serum calcium and phosphate level | |||
Secondary | changes of C reactive protein | |||
Secondary | changes of lipid profile | |||
Secondary | adverse reactions |
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