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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00365924
Collaborator
(none)
20
Enrollment
3
Locations
1
Arm
16
Duration (Months)
6.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Recombinant Human Parathyroid Hormone, PTH (Forteo)
Study Start Date :
Dec 1, 2006
Actual Study Completion Date :
Apr 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Other: Forteo

Drug: Forteo
Open label single arm study with Forteo as an intervention
Other Names:
  • Recombinant Human PTH 1-34

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo [12 months]

    Secondary Outcome Measures

    1. Changes in BMD and bone biomarkers following 12 months of therapy with Forteo [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Buenos Aires Argentina C1055AAK
    2 Pfizer Investigational Site Buenos Aires Argentina C1428AQK
    3 Pfizer Investigational Site Capital Federal - Buenos Aires Argentina C1012AAP

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00365924
    Other Study ID Numbers:
    • A9001294
    First Posted:
    Aug 18, 2006
    Last Update Posted:
    Mar 23, 2009
    Last Verified:
    Jun 1, 2008
    Keywords provided by , ,
    12 month therapy with postmenopausal women with osteoporosis to examine changes in bone quality parameters
    Additional relevant MeSH terms:
    Osteoporosis
    Teriparatide

    Study Results

    No Results Posted as of Mar 23, 2009