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

This study has been withdrawn prior to enrollment.
University of Kansas
Information provided by (Responsible Party):
Leland Graves III, MD, University of Kansas Medical Center Research Institute Identifier:
First received: June 30, 2006
Last updated: January 14, 2013
Last verified: January 2013
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 Intervention
Drug: teriparatide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Therapy With Teriparatide (Recombinant Parathyroid Hormone (1-34) on Vascular Compliance and Osteoprotegerin/RANKL

Resource links provided by NLM:

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • 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:
  • CRP levels [ Time Frame: Baseline and at 6 months of therapy ]

Enrollment: 0
Study Start Date: June 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: teriparatide
Other Name: Forteo

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

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00347737

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Leland Graves III, MD
University of Kansas
Principal Investigator: Leland Graves, III, MD University of Kansas Medical Center
  More Information

Responsible Party: Leland Graves III, MD, Associate Professor and Division Director, University of Kansas Medical Center Research Institute Identifier: NCT00347737     History of Changes
Other Study ID Numbers: 10386
Study First Received: June 30, 2006
Last Updated: January 14, 2013

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on April 28, 2017