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Trial record 7 of 97 for:    Open Studies | "Peritoneal Dialysis"

Alendronate for Vascular Calcification in Peritoneal Dialysis Patients?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by Far Eastern Memorial Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00299572
First received: March 5, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can Alendronate Suppress Aortic and Coronary Artery Calcification and Improve Bone Mineral Density in Chronic Peritoneal Dialysis Patients?

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Not yet recruiting
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

No publications provided

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

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

Additional relevant MeSH terms:
Calcinosis
Vascular Calcification
Calcium Metabolism Disorders
Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014