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

Information source: Papageorgiou General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: ibandronate (Drug); teriparatide (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Papageorgiou General Hospital

Official(s) and/or principal investigator(s):
Efstathios Mitsopoulos, MD, Principal Investigator, Affiliation: Papageorgiou General Hospital, Thessaloniki, Greece

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.

Clinical Details

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients.

Secondary outcome: Effects of ibandronate and teriparatide on other bone disease markers

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Papageorgiou General Hospital, Thessaloniki 56403, Greece
Additional Information

Starting date: July 2006
Last updated: October 28, 2014

Page last updated: August 23, 2015

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