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Alendronate for Vascular Calcification in Peritoneal Dialysis Patients?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00299572
Recruitment Status : Unknown
Verified March 2006 by Far Eastern Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 7, 2006
Last Update Posted : March 7, 2006
Information provided by:
Far Eastern Memorial Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Peritoneal Dialysis Drug: alendronate (Fosamax) Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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?
Study Start Date : March 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. changes of parathyroid hormone
  2. changes of serum calcium and phosphate level
  3. changes of C reactive protein
  4. changes of lipid profile
  5. adverse reactions

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00299572

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Contact: Chun-Fu Lai, M.D. 886-2-89667000 ext 1162

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Far Eastern Memorial Hospital
Taipei, Taiwan, 220
Sponsors and Collaborators
Far Eastern Memorial Hospital
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Principal Investigator: Chun-Fu Lai, M.D. Department of Internal Medicine, Far Eastern Memorial Hospital
Layout table for additonal information Identifier: NCT00299572    
Other Study ID Numbers: 94040
First Posted: March 7, 2006    Key Record Dates
Last Update Posted: March 7, 2006
Last Verified: March 2006
Keywords provided by Far Eastern Memorial Hospital:
peritoneal dialysis
vascular calcification
bone mineral density
Additional relevant MeSH terms:
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Vascular Calcification
Calcium Metabolism Disorders
Metabolic Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs