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

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00446589
• Other study ID #: 47b/31-1-2005
• Status: Terminated
• Phase: Phase 4
• First received: March 12, 2007
• Last updated: October 28, 2014
• Start date: July 2006

Study information

• Verified date: October 2014
• Source: Papageorgiou General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• ibandronate
iv 1mg ibandronate monthly for one year
• teriparatide
sc injection using a pen like device during every hemodialysis session (thrice a week)

Locations

Country	Name	City	State
Greece	Papageorgiou General Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Papageorgiou General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients.		one year	Yes
Secondary	Effects of ibandronate and teriparatide on other bone disease markers		one year	Yes