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

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NCT00365924

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Study Location
Pfizer Investigational Site
Buenos Aires, , C1055AAK, Argentina
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoporosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Postmenopausal women with osteoporosis

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
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 CenterPfizer
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