A Comparison of PF708 and Forteo in Osteoporosis Patients
A Randomized Study Comparing the Effects of PF708 and Forteo in Patients With Osteoporosis
1 other identifier
interventional
181
1 country
26
Brief Summary
The purpose of this study is to compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2016
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 21, 2016
CompletedFirst Posted
Study publicly available on registry
December 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMay 23, 2018
May 1, 2018
1.4 years
December 21, 2016
May 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Blood levels of anti-drug antibody (ADA) against teriparatide
24 weeks
Secondary Outcomes (5)
Mean percentage change in lumbar-spine bone mineral density (BMD)
24 weeks
Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP)
24 weeks
Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX)
24 weeks
Plasma maximum concentration (Cmax) of teriparatide
4 hours
Plasma area-under-the-curve (AUC) of teriparatide
4 hours
Study Arms (2)
Teriparatide (PF708)
EXPERIMENTALPF708 20 mcg once-daily subcutaneous injection for 24 weeks
Teriparatide (Forteo)
ACTIVE COMPARATORForteo 20 mcg once-daily subcutaneous injection for 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- If female, ≥5 years postmenopausal at the time of screening, with a DXA-derived BMD value at least 1 standard deviation (SD) below the average of young, healthy women
- 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)
You may not qualify if:
- Treatment with oral bisphosphonates (once daily or once weekly) within 6 months of screening
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfenex, Inclead
Study Sites (26)
Radiant Research
Birmingham, Alabama, 35211, United States
The Orthopaedic Group
Mobile, Alabama, 36608, United States
Radiant Research
Chandler, Arizona, 85224, United States
Radiant Research
Mesa, Arizona, 85213, United States
SunValley Arthritis Center
Peoria, Arizona, 85381, United States
Radiant Research
Phoenix, Arizona, 85020, United States
Radiant Research
Colorado Springs, Colorado, 80909, United States
OB-GYN Associates of Mid-Florida
Leesburg, Florida, 34748, United States
Atlanta Research Center
Atlanta, Georgia, 30319, United States
Radiant Research
Chicago, Illinois, 60602, United States
Radiant Research
Bridgeton, Missouri, 63044, United States
Radiant Research
Papillion, Nebraska, 68046, United States
Radiant Research
Henderson, Nevada, 89074, United States
Radiant Research
Las Vegas, Nevada, 89128, United States
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, 87106, United States
Lillestol Research
Fargo, North Dakota, 58103, United States
Radiant Research
Akron, Ohio, 44311, United States
Radiant Research
Cincinnati, Ohio, 45236, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Pennsylvania Regional Center for Arthritis & Osteoporosis Research
Wyomissing, Pennsylvania, 19610, United States
Radiant Research
Dallas, Texas, 75231, United States
Radiant Research
Plano, Texas, 75093, United States
Radiant Research
San Antonio, Texas, 78229, United States
Radiant Research
San Antonio, Texas, 78240, United States
Spectrum Medical
Danville, Virginia, 24541, United States
Radiant Research
Puyallup, Washington, 98372, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hubert C Chen, MD
Pfenex, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2016
First Posted
December 23, 2016
Study Start
December 1, 2016
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
May 23, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share