Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Information provided by (Responsible Party):
Efstathios Mitsopoulos, Papageorgiou General Hospital
ClinicalTrials.gov Identifier:
NCT00446589
First received: March 12, 2007
Last updated: October 28, 2014
Last verified: October 2014

March 12, 2007
October 28, 2014
July 2006
Not Provided
Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00446589
47b/31-1-2005
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