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The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density

NCT00446589 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2014-10-29

No results posted yet for this study

Summary

Hemodialysis patients with low bone density (total hip T-score \<-2.5) will be assigned to receive teriparatide (those with histologic confirmation of adynamic bone disease) or ibandronate (subjects with increased osteoclast number on bone biopsy).

Follow-up period: one year. A second bone biopsy at the end of the study.

Conditions

Interventions

DRUG

ibandronate

iv 1mg ibandronate monthly for one year

DRUG

teriparatide

sc injection using a pen like device during every hemodialysis session (thrice a week)

Sponsors & Collaborators

  • Papageorgiou General Hospital

    lead OTHER

Principal Investigators

  • Efstathios Mitsopoulos, MD · Papageorgiou General Hospital, Thessaloniki, Greece

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00446589 on ClinicalTrials.gov