NCT00299572

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 7, 2006

Status Verified

March 1, 2006

First QC Date

March 5, 2006

Last Update Submit

March 5, 2006

Conditions

Peritoneal Dialysis

Keywords

alendronateperitoneal dialysisvascular calcificationbone mineral density

Outcome Measures

Primary Outcomes (2)

  • 1.Changes of calcification score of coronary arteries and aorta

  • 2.Changes of bone density

Secondary Outcomes (5)

  • changes of parathyroid hormone

  • changes of serum calcium and phosphate level

  • changes of C reactive protein

  • changes of lipid profile

  • adverse reactions

Interventions

alendronate (Fosamax)DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, 220, Taiwan

Location

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: 34231877DERIVED

MeSH Terms

Conditions

Vascular Calcification

Interventions

Alendronate

Condition Hierarchy (Ancestors)

CalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Chun-Fu Lai, M.D.

    Department of Internal Medicine, Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Fu Lai, M.D.

CONTACT

886-2-89667000s821052@yahoo.com.tw

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

March 5, 2006

First Posted

March 7, 2006

Study Start

March 1, 2006

Study Completion

December 1, 2006

Last Updated

March 7, 2006

Record last verified: 2006-03

Locations

TW(1)