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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by Papageorgiou General Hospital.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Papageorgiou General Hospital

ClinicalTrials.gov Identifier:

NCT00446589

First received: March 12, 2007

Last updated: June 5, 2008

Last verified: June 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 12, 2007

Last Updated Date

June 5, 2008

Start Date ^ICMJE

July 2006

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00446589 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effects of ibandronate and teriparatide on other bone disease markers [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

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)

Study Arm (s)

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

Intervention: Drug: teriparatide
Experimental: I
Hemodialysis pts suffering from osteoporosis who received iv ibandronate

Intervention: Drug: ibandronate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Greece

Administrative Information

NCT Number ^ICMJE

NCT00446589

Other Study ID Numbers ^ICMJE

47b/31-1-2005

Has Data Monitoring Committee

Not Provided

Responsible Party

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

Study Sponsor ^ICMJE

Papageorgiou General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Efstathios Mitsopoulos, MD

Papageorgiou General Hospital, Thessaloniki, Greece

Information Provided By

Papageorgiou General Hospital

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top