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
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: ibandronate (Drug); teriparatide (Drug)
Phase: Phase 4
Status: Active, not recruiting
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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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: June 5, 2008
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