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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
  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:

U.S. FDA Resources

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
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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
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, MD, Papageorgiou General Hospital, Thessaloniki, Greece
ClinicalTrials.gov Identifier: NCT00446589     History of Changes
Other Study ID Numbers: 47b/31-1-2005
Study First Received: March 12, 2007
Last Updated: June 5, 2008
Health Authority: Greece: Ministry of Health and Welfare

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

ClinicalTrials.gov processed this record on May 21, 2013