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

Phase 4

Terminated

• Conditions: Osteoporosis
• Interventions: Drug: teriparatide; Drug: ibandronate

• Registration Number: NCT00446589
• Lead Sponsor: Papageorgiou General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-03-12
• Study First Submitted QC: 2007-03-12
• Study First Posted: 2007-03-13
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
F	teriparatide	HD pts suffering from osteoporosis and adynamic bone disease who received teriparatide
I	ibandronate	Hemodialysis pts suffering from osteoporosis who received iv ibandronate

Primary Outcome Measures

Name	Time	Method
Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients.	one year

Secondary Outcome Measures

Name	Time	Method
Effects of ibandronate and teriparatide on other bone disease markers	one year

Trial Locations

Locations (1)

Papageorgiou General Hospital; 🇬🇷 Thessaloniki, Greece