A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Forteo

March 20, 2009 updated by: Pfizer

A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Recombinant Human Parathyroid Hormone, PTH (Forteo)

This methodology trial will be conducted in patients with osteoporosis and will measure the changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone density following therapy with the approved drug, Forteo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1428AQK
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1055AAK
        • Pfizer Investigational Site
      • Capital Federal - Buenos Aires, Argentina, C1012AAP
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal women with osteoporosis

Exclusion Criteria:

  • Any therapies or products affecting bone turnover within 12 months of Screening.
  • Bisphosphonate treatment >1 month in total duration at any time in the past.
  • In addition, patients must be bisphosphonate-treatment-free for at least 12 months prior to Screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Forteo
Drug: Forteo
Open label single arm study with Forteo as an intervention
Other Names:
  • Recombinant Human PTH 1-34

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in BMD and bone biomarkers following 12 months of therapy with Forteo
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

August 16, 2006

First Submitted That Met QC Criteria

August 16, 2006

First Posted (Estimate)

August 18, 2006

Study Record Updates

Last Update Posted (Estimate)

March 23, 2009

Last Update Submitted That Met QC Criteria

March 20, 2009

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9001294

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe