NCT00365924
Completed
Not Applicable
A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Recombinant Human Parathyroid Hormone, PTH (Forteo)
Overview
- Phase
- Not Applicable
- Intervention
- Forteo
- Conditions
- Osteoporosis
- Sponsor
- Pfizer
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
Forteo
Intervention: Forteo
Outcomes
Primary Outcomes
Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo
Time Frame: 12 months
Secondary Outcomes
- Changes in BMD and bone biomarkers following 12 months of therapy with Forteo(12 months)
Study Sites (1)
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