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

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ClinicalTrials.gov Identifier: NCT00347737
Recruitment Status : Withdrawn
First Posted : July 4, 2006
Last Update Posted : January 16, 2013
Sponsor:
Collaborator:
University of Kansas
Information provided by (Responsible Party):
Leland Graves III, MD, University of Kansas Medical Center

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
Osteoporosis Drug: teriparatide Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 : June 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Teriparatide
Drug: teriparatide
Teriparatide
Other Name: Forteo



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 [ Time Frame: baseline, 3, and 6 months ]

Secondary Outcome Measures :
  1. CRP levels [ Time Frame: Baseline and at 6 months of therapy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347737


Locations
United States, Kansas
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

Responsible Party: Leland Graves III, MD, Associate Professor and Division Director, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00347737     History of Changes
Other Study ID Numbers: 10386
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs