The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00446589
Recruitment Status : Terminated (due to financial problems)
First Posted : March 13, 2007
Last Update Posted : October 29, 2014
Information provided by (Responsible Party):
Efstathios Mitsopoulos, Papageorgiou General Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Osteoporosis Drug: ibandronate Drug: teriparatide Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2006

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Effects of ibandronate and teriparatide on other bone disease markers [ Time Frame: one year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00446589

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

Responsible Party: Efstathios Mitsopoulos, Nephrologist, Papageorgiou General Hospital Identifier: NCT00446589     History of Changes
Other Study ID Numbers: 47b/31-1-2005
First Posted: March 13, 2007    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014

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