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

October 28, 2014 updated by: Efstathios Mitsopoulos, Papageorgiou General Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 56403
        • Papageorgiou General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bone mineral density (T-score<-2.5)
  • Adynamic bone disease for the teriparatide group
  • Increased osteoclast number on bone biopsy (high turnover) for the ibandronate group
  • Calcium greater than 8.1 mg/dl

Exclusion Criteria:

  • Suspected carcinoma
  • Unstable clinical setting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: F
HD pts suffering from osteoporosis and adynamic bone disease who received teriparatide
Drug: teriparatide
sc injection using a pen like device during every hemodialysis session (thrice a week)
Experimental: I
Hemodialysis pts suffering from osteoporosis who received iv ibandronate
Drug: ibandronate
iv 1mg ibandronate monthly for one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Effects of ibandronate and teriparatide on other bone disease markers
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papageorgiou General Hospital

Investigators

  • Principal Investigator: Efstathios Mitsopoulos, MD, Papageorgiou General Hospital, Thessaloniki, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 13, 2007

Study Record Updates

Last Update Posted (Estimate)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 47b/31-1-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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