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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This study has been withdrawn prior to enrollment.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
History of Changes

June 30, 2006
January 14, 2013
June 2006
May 2008   (final data collection date for primary outcome measure)
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 ]
The study measures changes in vascular compliance with teriparatide 1 hour, 3 months, and 6 months after initiating teriparatide. Osteoprotegerin and RANKL levels will be measured at baseline, 3, and 6 months.
Complete list of historical versions of study NCT00347737 on ClinicalTrials.gov Archive Site
CRP levels [ Time Frame: Baseline and at 6 months of therapy ] [ Designated as safety issue: No ]
CRP levels will be measured before starting teriparatide and after 6 months of therapy.
Not Provided
Not Provided
 
The Effects of Therapy With Teriparatide on Vascular Compliance and Osteoprotegerin/RANKL
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).

Research subjects participation is about 6 months. Subjects will give themselves daily injections of teriparatide after instruction on technique.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis
Drug: teriparatide
Teriparatide
Other Name: Forteo
Experimental: 1
Teriparatide
Intervention: Drug: teriparatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00347737
10386
No
Leland Graves III, MD, University of Kansas Medical Center Research Institute
Leland Graves III, MD
University of Kansas
Principal Investigator: Leland Graves, III, MD University of Kansas
University of Kansas
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP