search
Back to results

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

Primary Purpose

Osteoporosis

Status
Terminated
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
ibandronate
teriparatide
Sponsored by
Papageorgiou General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Papageorgiou General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

F

I

Arm Description

HD pts suffering from osteoporosis and adynamic bone disease who received teriparatide

Hemodialysis pts suffering from osteoporosis who received iv ibandronate

Outcomes

Primary Outcome Measures

Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients.

Secondary Outcome Measures

Effects of ibandronate and teriparatide on other bone disease markers

Full Information

First Posted
March 12, 2007
Last Updated
October 28, 2014
Sponsor
Papageorgiou General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00446589
Brief Title
The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
due to financial problems
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Papageorgiou General Hospital

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
F
Arm Type
Experimental
Arm Description
HD pts suffering from osteoporosis and adynamic bone disease who received teriparatide
Arm Title
I
Arm Type
Experimental
Arm Description
Hemodialysis pts suffering from osteoporosis who received iv ibandronate
Intervention Type
Drug
Intervention Name(s)
ibandronate
Intervention Description
iv 1mg ibandronate monthly for one year
Intervention Type
Drug
Intervention Name(s)
teriparatide
Intervention Description
sc injection using a pen like device during every hemodialysis session (thrice a week)
Primary Outcome Measure Information:
Title
Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Effects of ibandronate and teriparatide on other bone disease markers
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Efstathios Mitsopoulos, MD
Organizational Affiliation
Papageorgiou General Hospital, Thessaloniki, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Papageorgiou General Hospital
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs