The Effects of Therapy With Teriparatide on Vascular Compliance and Osteoprotegerin/RANKL

NCT ID: NCT00347737

Last Updated: 2013-01-16

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to determine what effect teriparatide will have on vascular (blood vessel) compliance and osteoprotegerin (bone fluid)and RANKL levels (bone cells).

Detailed Description

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Research subjects participation is about 6 months. Subjects will give themselves daily injections of teriparatide after instruction on technique.

Conditions

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Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Teriparatide

Group Type EXPERIMENTAL

teriparatide

Intervention Type DRUG

Teriparatide

Interventions

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teriparatide

Teriparatide

Intervention Type DRUG

Other Intervention Names

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Forteo

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women and men over the age of 40 who are starting therapy with teriparatide

Exclusion Criteria

* Patients with diabetes mellitus
* current smokers
* patients with a history of organ transplantation
* Patients currently of previously on glucocorticoid therapy within the past year
* Patients with serum creatinine above 1.5 mg/dl, patients with uncontrolled hypertension (BP 140/90 or greater)
* Patients ineligible for teriparatide therapy: History of metabolic bone disease other than osteoporosis
* History of radiation therapy
* Patients pregnant or nursing
* History of bone metastasis or skeletal malignancies
* History of hypercalcemia
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas

OTHER

Sponsor Role collaborator

Leland Graves III, MD

OTHER

Sponsor Role lead

Responsible Party

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Leland Graves III, MD

Associate Professor and Division Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Leland Graves, III, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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10386

Identifier Type: -

Identifier Source: org_study_id

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