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Alendronate for Vascular Calcification in Peritoneal Dialysis Patients?
This study is not yet open for participant recruitment.
Verified by Far Eastern Memorial Hospital, March 2006
Sponsored by: Far Eastern Memorial Hospital
Information provided by: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00299572
  Purpose

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.


Condition Intervention Phase
Peritoneal Dialysis
Drug: alendronate (Fosamax)
Phase IV

MedlinePlus related topics: Kidney Failure Minerals
Drug Information available for: Alendronate Alendronate sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Can Alendronate Suppress Aortic and Coronary Artery Calcification and Improve Bone Mineral Density in Chronic Peritoneal Dialysis Patients?

Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • 1.Changes of calcification score of coronary arteries and aorta
  • 2.Changes of bone density

Secondary Outcome Measures:
  • changes of parathyroid hormone
  • changes of serum calcium and phosphate level
  • changes of C reactive protein
  • changes of lipid profile
  • adverse reactions

Estimated Enrollment: 50
Study Start Date: March 2006
Estimated Study Completion Date: December 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299572

Contacts
Contact: Chun-Fu Lai, M.D. 886-2-89667000 ext 1162 s821052@yahoo.com.tw

Locations
Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan, 220
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Chun-Fu Lai, M.D. Department of Internal Medicine, Far Eastern Memorial Hospital
  More Information

Study ID Numbers: 94040
Study First Received: March 5, 2006
Last Updated: March 5, 2006
ClinicalTrials.gov Identifier: NCT00299572  
Health Authority: Taiwan: Department of Health

Keywords provided by Far Eastern Memorial Hospital:
alendronate
peritoneal dialysis
vascular calcification
bone mineral density

Study placed in the following topic categories:
Alendronate

Additional relevant MeSH terms:
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009