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Trial record 1 of 1 for:    NCT00365924
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A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Forteo

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ClinicalTrials.gov Identifier: NCT00365924
Recruitment Status : Completed
First Posted : August 18, 2006
Last Update Posted : March 23, 2009
Sponsor:
Information provided by:
Pfizer

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
Osteoporosis Drug: Forteo Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : December 2006
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Forteo Drug: Forteo
Open label single arm study with Forteo as an intervention
Other Name: Recombinant Human PTH 1-34




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

Secondary Outcome Measures :
  1. Changes in BMD and bone biomarkers following 12 months of therapy with Forteo [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365924


Locations
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Argentina
Pfizer Investigational Site
Buenos Aires, Argentina, C1055AAK
Pfizer Investigational Site
Buenos Aires, Argentina, C1428AQK
Pfizer Investigational Site
Capital Federal - Buenos Aires, Argentina, C1012AAP
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00365924    
Other Study ID Numbers: A9001294
First Posted: August 18, 2006    Key Record Dates
Last Update Posted: March 23, 2009
Last Verified: June 2008
Keywords provided by Pfizer:
12 month therapy with postmenopausal women with osteoporosis to examine changes in bone quality parameters
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents