A Comparison of PF708 and Forteo in Osteoporosis Patients

May 21, 2018 updated by: Pfenex, Inc

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 81 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfenex, Inc

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • PF708-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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