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

NCT ID: NCT00365924

Last Updated: 2009-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-04-30

Brief Summary

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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

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Conditions

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Osteoporosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Forteo

Group Type OTHER

Forteo

Intervention Type DRUG

Open label single arm study with Forteo as an intervention

Interventions

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Forteo

Open label single arm study with Forteo as an intervention

Intervention Type DRUG

Other Intervention Names

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Recombinant Human PTH 1-34

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Buenos Aires, , Argentina

Site Status

Pfizer Investigational Site

Buenos Aires, , Argentina

Site Status

Pfizer Investigational Site

Capital Federal - Buenos Aires, , Argentina

Site Status

Countries

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Argentina

Related Links

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Other Identifiers

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A9001294

Identifier Type: -

Identifier Source: org_study_id

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