A Comparison of PF708 and Forteo in Osteoporosis Patients

• ClinicalTrials.gov Identifier: NCT03002428
• Recruitment Status: Completed
• First Posted: December 23, 2016
• Last Update Posted: May 23, 2018
• Sponsor: Pfenex, Inc
• Information provided by (Responsible Party): Pfenex, Inc

Tracking Information

• First Submitted Date: December 21, 2016
• First Posted Date: December 23, 2016
• Last Update Posted Date: May 23, 2018
• Actual Study Start Date: December 2016
• Actual Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 22, 2016): Blood levels of anti-drug antibody (ADA) against teriparatide [ Time Frame: 24 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 21, 2018)

• Mean percentage change in lumbar-spine bone mineral density (BMD) [ Time Frame: 24 weeks ]
• Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP) [ Time Frame: 24 weeks ]
• Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX) [ Time Frame: 24 weeks ]
• Plasma maximum concentration (Cmax) of teriparatide [ Time Frame: 4 hours ]
• Plasma area-under-the-curve (AUC) of teriparatide [ Time Frame: 4 hours ]

Original Secondary Outcome Measures (submitted: December 22, 2016)

• Plasma area-under-the-curve (AUC) of teriparatide [ Time Frame: 4 hours ]
• Plasma maximum concentration (Cmax) of teriparatide [ Time Frame: 4 hours ]
• Mean percentage change in lumbar-spine bone mineral density (BMD) [ Time Frame: 24 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Comparison of PF708 and Forteo in Osteoporosis Patients
• Official Title: A Randomized Study Comparing the Effects of PF708 and Forteo in Patients With Osteoporosis
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Osteoporosis

Intervention

• Drug: Teriparatide (PF708)
  Subcutaneous injection
• Drug: Teriparatide (Forteo)
  Subcutaneous injection

Study Arms

• Experimental: Teriparatide (PF708)
  PF708 20 mcg once-daily subcutaneous injection for 24 weeks
  Intervention: Drug: Teriparatide (PF708)
• Active Comparator: Teriparatide (Forteo)
  Forteo 20 mcg once-daily subcutaneous injection for 24 weeks
  Intervention: Drug: Teriparatide (Forteo)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 30, 2017): 181
• Original Estimated Enrollment (submitted: December 22, 2016): 168
• Actual Study Completion Date: May 2018
• Actual Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03002428
• Other Study ID Numbers: PF708-301
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Pfenex, Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfenex, Inc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Hubert C Chen, MD; Pfenex, Inc

• PRS Account: Pfenex, Inc
• Verification Date: May 2018