A Comparison of PF708 and Forteo in Osteoporosis Patients

A Randomized Study Comparing the Effects of PF708 and Forteo in Patients With Osteoporosis

The purpose of this study is to compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Teriparatide (PF708); Drug: Teriparatide (Forteo)

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
• Enrollment (Actual): 181
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Radiant Research
    • Mobile, Alabama, United States, 36608
      • The Orthopaedic Group
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Radiant Research
    • Mesa, Arizona, United States, 85213
      • Radiant Research
    • Peoria, Arizona, United States, 85381
      • SunValley Arthritis Center
    • Phoenix, Arizona, United States, 85020
      • Radiant Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Radiant Research
  • Florida
    • Leesburg, Florida, United States, 34748
      • OB-GYN Associates of Mid-Florida
  • Georgia
    • Atlanta, Georgia, United States, 30319
      • Atlanta Research Center
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Radiant Research
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Radiant Research
  • Nebraska
    • Papillion, Nebraska, United States, 68046
      • Radiant Research
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Radiant Research
    • Las Vegas, Nevada, United States, 89128
      • Radiant Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Clinical Research & Osteoporosis Center
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Lillestol Research
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research
    • Cincinnati, Ohio, United States, 45236
      • Radiant Research
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Wyomissing, Pennsylvania, United States, 19610
      • Pennsylvania Regional Center for Arthritis & Osteoporosis Research
  • Texas
    • Dallas, Texas, United States, 75231
      • Radiant Research
    • Plano, Texas, United States, 75093
      • Radiant Research
    • San Antonio, Texas, United States, 78229
      • Radiant Research
    • San Antonio, Texas, United States, 78240
      • Radiant Research
  • Virginia
    • Danville, Virginia, United States, 24541
      • Spectrum Medical
  • Washington
    • Puyallup, Washington, United States, 98372
      • Radiant Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teriparatide (PF708); PF708 20 mcg once-daily subcutaneous injection for 24 weeks	Drug: Teriparatide (PF708); Subcutaneous injection
Active Comparator: Teriparatide (Forteo); Forteo 20 mcg once-daily subcutaneous injection for 24 weeks	Drug: Teriparatide (Forteo); Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood levels of anti-drug antibody (ADA) against teriparatide	24 weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Pfenex, Inc
• Investigators: Study Director: Hubert C Chen, MD, Pfenex, Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimate): December 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 21, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Teriparatide
• Other Study ID Numbers: PF708-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No