The Effects of Therapy With Teriparatide on Vascular Compliance and Osteoprotegerin/RANKL - Full Text View

Sponsored by:	University of Kansas
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00347737

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

MedlinePlus related topics: Osteoporosis

Drug Information available for: Parathyroid Teriparatide Teriparatide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	The Effects of Therapy With Teriparatide (Recombinant Parathyroid Hormone (1-34) on Vascular Compliance and Osteoprotegerin/RANKL

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 ]

Estimated Enrollment:	20
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Teriparatide	Drug: teriparatide Teriparatide

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347737

Contacts

Contact: Lisa Hays, MD

913-588-6022

Lhays@kumc.edu

Locations

United States, Kansas
University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

University of Kansas

Investigators

Principal Investigator:

Leland Graves, III, MD

University of Kansas

More Information

Responsible Party:	University of Kansas Medical Center ( Leland Graves, III, MD )
Study ID Numbers:	10386
Study First Received:	June 30, 2006
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00347737
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Musculoskeletal Diseases
Teriparatide
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009