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

NCT00261625 | Completed Phase 4

• 1 other identifier: 940706
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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) patients have not been investigated. Etidronate, another bisphosphonate, can suppress the extent of coronary artery calcification in chronic hemodialysis patients. The hypothesis of this study is that alendronate can increase bone mineral density and suppress aortic and coronary artery calcification in chronic peritoneal dialysis patients.

Conditions

End-Stage Renal Disease; Osteoporosis

Keywords

peritoneal dialysis; artery calcification; bone mineral density

Outcome Measures

Primary Outcomes (2)

• extent of aortic and coronary artery calcification with and without the use of alendronate

• bone mineral density with and without the use of alendronate

Secondary Outcomes (1)

• serum levels of calcium, phosphorus and parathyroid hormone

Interventions

alendronate DRUG

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Related Publications (1)

• Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.

  PMID: 34231877 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Osteoporosis

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Tze-Wah Kao, Master

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2005
• First Posted: December 5, 2005
• Study Start: August 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: January 5, 2009

Record last verified: 2008-12