Clincosm LogoSign in Get a demo

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

Sponsor
Leland Graves III, MD (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00347737
Collaborator
University of Kansas (Other)
0
Enrollment
1
Location
1
Arm
23
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of Therapy With Teriparatide (Recombinant Parathyroid Hormone (1-34) on Vascular Compliance and Osteoprotegerin/RANKL
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
May 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Teriparatide

Drug: teriparatide
Teriparatide
Other Names:
  • Forteo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The study measures changes in vascular compliance with teriparatide 1 hour, 3 months, and 6 months after initiating teriparatide. Osteoprotegerin and RANKL levels [baseline, 3, and 6 months]

    Secondary Outcome Measures

    1. CRP levels [Baseline and at 6 months of therapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kansas Medical Center Kansas City Kansas United States 66160

    Sponsors and Collaborators

    • Leland Graves III, MD
    • University of Kansas

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leland Graves III, MD, Associate Professor and Division Director, University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT00347737
    Other Study ID Numbers:
    • 10386
    First Posted:
    Jul 4, 2006
    Last Update Posted:
    Jan 16, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Osteoporosis
    Teriparatide

    Study Results

    No Results Posted as of Jan 16, 2013