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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00347737
• Other study ID #: 10386
• Status: Withdrawn
• Phase: N/A
• First received: June 30, 2006
• Last updated: January 14, 2013
• Start date: June 2006
• Est. completion date: May 2008

Study information

• Verified date: January 2013
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• teriparatide
Teriparatide

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Leland Graves III, MD	University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The study measures changes in vascular compliance with teriparatide 1 hour, 3 months, and 6 months after initiating teriparatide. Osteoprotegerin and RANKL levels		baseline, 3, and 6 months	No
Secondary	CRP levels		Baseline and at 6 months of therapy	No