A Comparison of PF708 and Forteo in Osteoporosis Patients
- Conditions
- Osteoporosis
- Interventions
- Registration Number
- NCT03002428
- Lead Sponsor
- Pfenex, Inc
- Brief Summary
The purpose of this study is to compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis.
- Detailed Description
This is a randomized, multi-center study conducted in the United States. Men and women with osteoporosis will be enrolled in a parallel-group, open-label study design to compare the effects of PF708 and Forteo after 24 weeks of treatment. Half of the subjects will be randomized to receive PF708, and the other half will be randomized to receive Forteo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 181
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Teriparatide (Forteo) Teriparatide (Forteo) Forteo 20 mcg once-daily subcutaneous injection for 24 weeks Teriparatide (PF708) Teriparatide (PF708) PF708 20 mcg once-daily subcutaneous injection for 24 weeks
- Primary Outcome Measures
Name Time Method Blood levels of anti-drug antibody (ADA) against teriparatide 24 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (10)
Atlanta Research Center
🇺🇸Atlanta, Georgia, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
New Mexico Clinical Research & Osteoporosis Center
🇺🇸Albuquerque, New Mexico, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
The Orthopaedic Group
🇺🇸Mobile, Alabama, United States
Pennsylvania Regional Center for Arthritis & Osteoporosis Research
🇺🇸Wyomissing, Pennsylvania, United States
SunValley Arthritis Center
🇺🇸Peoria, Arizona, United States
OB-GYN Associates of Mid-Florida
🇺🇸Leesburg, Florida, United States
Spectrum Medical
🇺🇸Danville, Virginia, United States
Radiant Research
🇺🇸Puyallup, Washington, United States