NCT00347737

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

June 30, 2006

Last Update Submit

January 14, 2013

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • CRP levels

    Baseline and at 6 months of therapy

Study Arms (1)

1

EXPERIMENTAL

Teriparatide

Drug: teriparatide

Interventions

teriparatideDRUG

Teriparatide

Also known as: Forteo
1

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women and men over the age of 40 who are starting therapy with teriparatide

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Leland Graves, III, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor and Division Director

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

June 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)