Osteoporosis
Conditions
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.
Interventions
DRUGTeriparatide (PF708)
Subcutaneous injection
Subcutaneous injection
Sponsors
Pfenex, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood levels of anti-drug antibody (ADA) against teriparatide | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed