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
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: ibandronate
Drug: teriparatide
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Papageorgiou General Hospital:

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

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

Enrollment: 19
Study Start Date: July 2006
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446589

Locations
Greece
Papageorgiou General Hospital
Thessaloniki, Greece, 56403
Sponsors and Collaborators
Papageorgiou General Hospital
Investigators
Principal Investigator: Efstathios Mitsopoulos, MD Papageorgiou General Hospital, Thessaloniki, Greece
  More Information

No publications provided

Responsible Party: Efstathios Mitsopoulos, Nephrologist, Papageorgiou General Hospital
ClinicalTrials.gov Identifier: NCT00446589     History of Changes
Other Study ID Numbers: 47b/31-1-2005
Study First Received: March 12, 2007
Last Updated: October 28, 2014
Health Authority: Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Ibandronic acid
Teriparatide
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014