We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(due to financial problems)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00446589
First Posted: March 13, 2007
Last Update Posted: October 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Efstathios Mitsopoulos, Papageorgiou General Hospital
March 12, 2007
March 13, 2007
October 29, 2014
July 2006
Not Provided
Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients. [ Time Frame: one year ]
Not Provided
Complete list of historical versions of study NCT00446589 on ClinicalTrials.gov Archive Site
Effects of ibandronate and teriparatide on other bone disease markers [ Time Frame: one year ]
Not Provided
Not Provided
Not Provided
 
The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteoporosis
  • 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)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
Not Provided
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT00446589
47b/31-1-2005
Not Provided
Not Provided
Not Provided
Efstathios Mitsopoulos, Papageorgiou General Hospital
Papageorgiou General Hospital
Not Provided
Principal Investigator: Efstathios Mitsopoulos, MD Papageorgiou General Hospital, Thessaloniki, Greece
Papageorgiou General Hospital
October 2014

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