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

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
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

Responsible Party: Efstathios Mitsopoulos, Nephrologist, Papageorgiou General Hospital 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:
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on May 25, 2016