A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Forteo
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Forteo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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: Other, Non-Randomized, Open Label, Single Group Assignment
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 CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Buenos Aires C1055AAK, Argentina; Recruiting
Pfizer Investigational Site, Buenos Aires C1428AQK, Argentina; Recruiting
Pfizer Investigational Site, Capital Federal - Buenos Aires C1012AAP, Argentina; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: December 2006
Ending date: May 2008
Last updated: April 9, 2008
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