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NCT00365924 Clinical Trial

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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00365924
Other study ID # A9001294
Secondary ID
Status Completed
Phase N/A
First received August 16, 2006
Last updated March 20, 2009
Start date December 2006
Est. completion date April 2008

Study information
Verified date June 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date April 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 70 Years
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• Forteo
Open label single arm study with Forteo as an intervention

Locations
Country Name City State
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Capital Federal - Buenos Aires

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo 12 months No
Secondary Changes in BMD and bone biomarkers following 12 months of therapy with Forteo 12 months No
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