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

Phase 4TerminatedNCT00446589

Papageorgiou General Hospital19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoporosis

Interventions

ibandronateDRUG

iv 1mg ibandronate monthly for one year

teriparatideDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Papageorgiou General Hospital

Thessaloniki, Greece

Outcomes

Primary Outcomes

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

Time frame: one year

Secondary Outcomes

Effects of ibandronate and teriparatide on other bone disease markers

Time frame: one year

Data from ClinicalTrials.gov

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