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
Information provided by:
Papageorgiou General Hospital Identifier:
First received: March 12, 2007
Last updated: June 5, 2008
Last verified: June 2008

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
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
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00446589

Papageorgiou General Hospital
Thessaloniki, Greece, 56403
Sponsors and Collaborators
Papageorgiou General Hospital
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 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:
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Ibandronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on October 21, 2014