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

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Forteo

• Registration Number: NCT00365924
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-16
• Study First Submitted QC: 2006-08-16
• Study First Posted: 2006-08-18
• Study Start: 2006-12
• Study Completion: 2008-04
• Status Verified: 2008-06
• Last Update Submitted: 2009-03-20
• Last Update Posted: 2009-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Forteo	Forteo	-

Primary Outcome Measures

Name	Time	Method
Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo	12 months

Secondary Outcome Measures

Name	Time	Method
Changes in BMD and bone biomarkers following 12 months of therapy with Forteo	12 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇦🇷 Capital Federal - Buenos Aires, Argentina