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)

Sponsor:

Information provided by (Responsible Party):

Efstathios Mitsopoulos, Papageorgiou General Hospital

ClinicalTrials.gov Identifier:

NCT00446589

First received: March 12, 2007

Last updated: October 28, 2014

Last verified: October 2014

History of Changes

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 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:

MedlinePlus related topics: Bone Density Bone Diseases Dialysis 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

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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:	Efstathios Mitsopoulos, Nephrologist, Papageorgiou General Hospital
ClinicalTrials.gov 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:


Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Ibandronic acid	Teriparatide Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016

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