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

Sponsored by:	Papageorgiou General Hospital
Information provided by:	Papageorgiou General Hospital
ClinicalTrials.gov Identifier:	NCT00446589

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 IV

MedlinePlus related topics: Bone Diseases Dialysis Kidney Failure Minerals Osteoporosis

Drug Information available for: Teriparatide Teriparatide acetate Ibandronate sodium Ibandronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

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
F: Experimental 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)
I: Experimental 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

Responsible Party:	Papageorgiou General Hospital, Thessaloniki, Greece ( Efstathios Mitsopoulos, MD )
Study ID Numbers:	47b/31-1-2005
Study First Received:	March 12, 2007
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00446589
Health Authority:	Greece: Ministry of Health and Welfare

Study placed in the following topic categories:

Ibandronic acid
Musculoskeletal Diseases
Teriparatide

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009