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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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F

HD pts suffering from osteoporosis and adynamic bone disease who received teriparatide

Group Type EXPERIMENTAL

teriparatide

Intervention Type DRUG

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

I

Hemodialysis pts suffering from osteoporosis who received iv ibandronate

Group Type EXPERIMENTAL

ibandronate

Intervention Type DRUG

iv 1mg ibandronate monthly for one year

Interventions

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ibandronate

iv 1mg ibandronate monthly for one year

Intervention Type DRUG

teriparatide

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

Intervention Type DRUG

Eligibility Criteria

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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