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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
University of Kansas
Information provided by (Responsible Party):
Leland Graves III, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00347737
First received: June 30, 2006
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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
Osteoporosis
Drug: teriparatide

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CRP levels [ Time Frame: Baseline and at 6 months of therapy ] [ Designated as safety issue: No ]

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
Teriparatide
Drug: teriparatide
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Leland Graves III, MD, Associate Professor and Division Director, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00347737     History of Changes
Other Study ID Numbers: 10386
Study First Received: June 30, 2006
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014