Back to resultsThe Effects of Therapy With Teriparatide on Vascular Compliance and Osteoprotegerin/RANKL
Primary Purpose
Osteoporosis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
teriparatide
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Teriparatide
Outcomes
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
Secondary Outcome Measures
CRP levels
Full Information
NCT ID
NCT00347737
First Posted
June 30, 2006
Last Updated
January 14, 2013
Sponsor
Leland Graves III, MD
Collaborators
University of Kansas
1. Study Identification
Unique Protocol Identification Number
NCT00347737
Brief Title
The Effects of Therapy With Teriparatide on Vascular Compliance and Osteoprotegerin/RANKL
Official Title
The Effects of Therapy With Teriparatide (Recombinant Parathyroid Hormone (1-34) on Vascular Compliance and Osteoprotegerin/RANKL
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Withdrawn
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leland Graves III, MD
Collaborators
University of Kansas
4. Oversight
Data Monitoring Committee
No
5. 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).
Detailed Description
Research subjects participation is about 6 months. Subjects will give themselves daily injections of teriparatide after instruction on technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Teriparatide
Intervention Type
Drug
Intervention Name(s)
teriparatide
Other Intervention Name(s)
Forteo
Intervention Description
Teriparatide
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
CRP levels
Time Frame
Baseline and at 6 months of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leland Graves, III, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Therapy With Teriparatide on Vascular Compliance and Osteoprotegerin/RANKL
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