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

This study is ongoing, but not recruiting participants.

First Received: March 12, 2007 Last Updated: June 5, 2008 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Bone Diseases Dialysis Kidney Failure Minerals Osteoporosis

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

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
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

No publications provided

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 History of Changes
Health Authority:	Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:

Ibandronic acid
Musculoskeletal Diseases
Teriparatide
Physiological Effects of Drugs
Osteoporosis, Postmenopausal

Osteoporosis
Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010