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A Comparison of PF708 and Forteo in Osteoporosis Patients

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Teriparatide (PF708)
Teriparatide (Forteo)
Sponsored by
Pfenex, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiant Research
  • The Orthopaedic Group
  • Radiant Research
  • Radiant Research
  • SunValley Arthritis Center
  • Radiant Research
  • Radiant Research
  • OB-GYN Associates of Mid-Florida
  • Atlanta Research Center
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • New Mexico Clinical Research & Osteoporosis Center
  • Lillestol Research
  • Radiant Research
  • Radiant Research
  • Altoona Center for Clinical Research
  • Pennsylvania Regional Center for Arthritis & Osteoporosis Research
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Spectrum Medical
  • Radiant Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Teriparatide (PF708)

Teriparatide (Forteo)

Arm Description

PF708 20 mcg once-daily subcutaneous injection for 24 weeks

Forteo 20 mcg once-daily subcutaneous injection for 24 weeks

Outcomes

Primary Outcome Measures

Blood levels of anti-drug antibody (ADA) against teriparatide

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2016
Last Updated
May 21, 2018
Sponsor
Pfenex, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03002428
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfenex, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teriparatide (PF708)
Arm Type
Experimental
Arm Description
PF708 20 mcg once-daily subcutaneous injection for 24 weeks
Arm Title
Teriparatide (Forteo)
Arm Type
Active Comparator
Arm Description
Forteo 20 mcg once-daily subcutaneous injection for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Teriparatide (PF708)
Intervention Description
Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Teriparatide (Forteo)
Intervention Description
Subcutaneous injection
Primary Outcome Measure Information:
Title
Blood levels of anti-drug antibody (ADA) against teriparatide
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Mean percentage change in lumbar-spine bone mineral density (BMD)
Time Frame
24 weeks
Title
Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP)
Time Frame
24 weeks
Title
Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX)
Time Frame
24 weeks
Title
Plasma maximum concentration (Cmax) of teriparatide
Time Frame
4 hours
Title
Plasma area-under-the-curve (AUC) of teriparatide
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert C Chen, MD
Organizational Affiliation
Pfenex, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
The Orthopaedic Group
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Radiant Research
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Radiant Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
SunValley Arthritis Center
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Radiant Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Radiant Research
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
OB-GYN Associates of Mid-Florida
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Atlanta Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30319
Country
United States
Facility Name
Radiant Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Radiant Research
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Radiant Research
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Radiant Research
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Radiant Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
New Mexico Clinical Research & Osteoporosis Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Radiant Research
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pennsylvania Regional Center for Arthritis & Osteoporosis Research
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Radiant Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Radiant Research
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Radiant Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Radiant Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Spectrum Medical
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Radiant Research
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Comparison of PF708 and Forteo in Osteoporosis Patients

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