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

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

Condition(s) targeted: Osteoporosis

Intervention: Forteo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo

Secondary outcome: Changes in BMD and bone biomarkers following 12 months of therapy with Forteo

Eligibility

Minimum age: 55 Years. Maximum age: 70 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, Buenos Aires C1055AAK, Argentina

Pfizer Investigational Site, Buenos Aires C1428AQK, Argentina

Pfizer Investigational Site, Capital Federal - Buenos Aires C1012AAP, Argentina

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: December 2006
Last updated: March 20, 2009

Page last updated: August 20, 2015

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