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

Information source: University of Kansas
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: teriparatide (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Leland Graves III, MD

Official(s) and/or principal investigator(s):
Leland Graves, III, MD, Principal Investigator, Affiliation: University of Kansas


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).

Clinical Details

Official title: The Effects of Therapy With Teriparatide (Recombinant Parathyroid Hormone (1-34) on Vascular Compliance and Osteoprotegerin/RANKL

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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: CRP levels

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


Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

University of Kansas Medical Center, Kansas City, Kansas 66160, United States
Additional Information

Starting date: June 2006
Last updated: January 14, 2013

Page last updated: August 20, 2015

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