A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Forteo
NCT00365924
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Postmenopausal women with osteoporosis
- 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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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 | 20 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | April 2008 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |