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Clinical Trials/NCT00365924
NCT00365924
Completed
Not Applicable

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

Pfizer1 site in 1 country20 target enrollmentDecember 2006
ConditionsOsteoporosis
InterventionsForteo
DrugsForteo

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.

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
April 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Pfizer

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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