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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

Tracking Information
First Submitted Date  ICMJE August 16, 2006
First Posted Date  ICMJE August 18, 2006
Last Update Posted Date March 23, 2009
Study Start Date  ICMJE December 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2006)
Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo
Change History Complete list of historical versions of study NCT00365924 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Changes in BMD and bone biomarkers following 12 months of therapy with Forteo [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2006)
Changes in BMD and bone biomarkers following 12 months of therapy with Forteo
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Forteo
Official Title  ICMJE A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Recombinant Human Parathyroid Hormone, PTH (Forteo)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Osteoporosis
Intervention  ICMJE Drug: Forteo
Open label single arm study with Forteo as an intervention
Other Name: Recombinant Human PTH 1-34
Study Arms  ICMJE Forteo
Intervention: Drug: Forteo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2006)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00365924
Other Study ID Numbers  ICMJE A9001294
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP