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

January 14, 2013 updated by: Leland Graves III, MD

The Effects of Therapy With Teriparatide (Recombinant Parathyroid Hormone (1-34) on Vascular Compliance and Osteoprotegerin/RANKL

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Teriparatide
Drug: teriparatide
Teriparatide
Other Names:
  • Forteo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The study measures changes in vascular compliance with teriparatide 1 hour, 3 months, and 6 months after initiating teriparatide. Osteoprotegerin and RANKL levels
Time Frame: baseline, 3, and 6 months
baseline, 3, and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
CRP levels
Time Frame: Baseline and at 6 months of therapy
Baseline and at 6 months of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leland Graves III, MD

Collaborators

University of Kansas

Investigators

  • Principal Investigator: Leland Graves, III, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10386

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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