Status:

COMPLETED

Can Alendronate Suppress Calcification and Improve Bone Density in Chronic Peritoneal Dialysis Patients?

Lead Sponsor:

National Taiwan University Hospital

Conditions:

End-Stage Renal Disease

Osteoporosis

Eligibility:

All Genders

20-80 years

Phase:

PHASE4

Brief Summary

Alendronate is a safe and effective drug for treating osteoporosis in post-menopausal women. However, its safety and efficacy in increasing bone mineral density in chronic peritoneal dialysis (PD) pat...

Detailed Description

Study Design The study is a prospective, randomized cross-over study. Fifty patients will be included. All participants are randomly allocated to either group 1 or group 2. Each group consists of 25 ...

Eligibility Criteria

Inclusion

  • Have received maintenance PD for more than 3 months at National Taiwan University Hospital,
  • Have high CPP level (≧50), and
  • Have chest X-ray proven aortic calcification or coronary artery calcification proven before.

Exclusion

  • Patients are excluded if they have any one of the following conditions:
  • Had been hospitalized in recent 3 months due to severe comorbid diseases,
  • Are hypersensitive to alendronate or any of its components,
  • Have esophageal diseases
  • Are not able to stand or sit upright for 30 minutes,
  • Have refractory hypocalcemia, or
  • Patients who are pregnant.

Key Trial Info

Start Date :

August 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2007

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00261625

Start Date

August 1 2005

End Date

October 1 2007

Last Update

January 5 2009

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