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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00446589

Enrollment

Registered

2007-03-13

Start date

2006-07-31

Completion date

Unknown

Last updated

2014-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

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.

Interventions

DRUGibandronate

iv 1mg ibandronate monthly for one year

DRUGteriparatide

sc injection using a pen like device during every hemodialysis session (thrice a week)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Effects of ibandronate and teriparatide on other bone disease markers	one year

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026