A Comparison of PF708 and Forteo in Osteoporosis Patients
NCT ID: NCT03002428
Last Updated: 2018-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
181 participants
INTERVENTIONAL
2016-12-31
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Teriparatide (PF708)
PF708 20 mcg once-daily subcutaneous injection for 24 weeks
Teriparatide (PF708)
Subcutaneous injection
Teriparatide (Forteo)
Forteo 20 mcg once-daily subcutaneous injection for 24 weeks
Teriparatide (Forteo)
Subcutaneous injection
Interventions
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Teriparatide (PF708)
Subcutaneous injection
Teriparatide (Forteo)
Subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* If male, has a DXA-derived BMD value at least 2 SD below the average of young, healthy men
* Able to use the pen injection device correctly
* Able to understand and sign the written Informed Consent Form (ICF)
Exclusion Criteria
* Any current or prior human PTH-derived products (e.g., Forteo, Teribone, Natpara), including for investigational purposes
* Immobility due to severe or chronically disabling conditions (e.g., stroke, Parkinson's disease, multiple sclerosis)
* History of metabolic bone diseases other than osteoporosis
* History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured)
* History of Paget's disease of bone
* History of prior external beam or implant radiation therapy involving the skeleton
* Active urolithiasis or primary hyperparathyroidism
30 Years
85 Years
ALL
No
Sponsors
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Pfenex, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Hubert C Chen, MD
Role: STUDY_DIRECTOR
Pfenex, Inc
Locations
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Radiant Research
Birmingham, Alabama, United States
The Orthopaedic Group
Mobile, Alabama, United States
Radiant Research
Chandler, Arizona, United States
Radiant Research
Mesa, Arizona, United States
SunValley Arthritis Center
Peoria, Arizona, United States
Radiant Research
Phoenix, Arizona, United States
Radiant Research
Colorado Springs, Colorado, United States
OB-GYN Associates of Mid-Florida
Leesburg, Florida, United States
Atlanta Research Center
Atlanta, Georgia, United States
Radiant Research
Chicago, Illinois, United States
Radiant Research
Bridgeton, Missouri, United States
Radiant Research
Papillion, Nebraska, United States
Radiant Research
Henderson, Nevada, United States
Radiant Research
Las Vegas, Nevada, United States
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, United States
Lillestol Research
Fargo, North Dakota, United States
Radiant Research
Akron, Ohio, United States
Radiant Research
Cincinnati, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Pennsylvania Regional Center for Arthritis & Osteoporosis Research
Wyomissing, Pennsylvania, United States
Radiant Research
Dallas, Texas, United States
Radiant Research
Plano, Texas, United States
Radiant Research
San Antonio, Texas, United States
Radiant Research
San Antonio, Texas, United States
Spectrum Medical
Danville, Virginia, United States
Radiant Research
Puyallup, Washington, United States
Countries
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Other Identifiers
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PF708-301
Identifier Type: -
Identifier Source: org_study_id
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