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CompletedNCT03002428Updated May 23, 2018

A Comparison of PF708 and Forteo in Osteoporosis Patients

A Phase 3 interventional study of Teriparatide (PF708) and Teriparatide (Forteo) in Osteoporosis, sponsored by Pfenex, Inc. Completed at 26 sites in United States. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-05-23.

Sponsored by Pfenex, Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
181
Allocation
Randomized
Ages
30 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Osteoporosis

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03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 181 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Pfenex, Inc is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
181 participants (actual)

Study arms

  • Experimental
    Teriparatide (PF708)

    PF708 20 mcg once-daily subcutaneous injection for 24 weeks

    Drug: Teriparatide (PF708)

  • Active comparator
    Teriparatide (Forteo)

    Forteo 20 mcg once-daily subcutaneous injection for 24 weeks

    Drug: Teriparatide (Forteo)

Interventions

  • DrugTeriparatide (PF708)

    Subcutaneous injection

  • DrugTeriparatide (Forteo)

    Subcutaneous injection

06

What researchers measure

Primary outcomes

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

    Time frame: 24 weeks

Secondary outcomes

  1. Mean percentage change in lumbar-spine bone mineral density (BMD)

    Time frame: 24 weeks

  2. Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP)

    Time frame: 24 weeks

  3. Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX)

    Time frame: 24 weeks

  4. Plasma maximum concentration (Cmax) of teriparatide

    Time frame: 4 hours

  5. Plasma area-under-the-curve (AUC) of teriparatide

    Time frame: 4 hours

07

Study locations

26 sites
  • Radiant Research
    Birmingham, Alabama 35211, United States
  • The Orthopaedic Group
    Mobile, Alabama 36608, United States
  • Radiant Research
    Chandler, Arizona 85224, United States
  • Radiant Research
    Mesa, Arizona 85213, United States
  • SunValley Arthritis Center
    Peoria, Arizona 85381, United States
  • Radiant Research
    Phoenix, Arizona 85020, United States
  • Radiant Research
    Colorado Springs, Colorado 80909, United States
  • OB-GYN Associates of Mid-Florida
    Leesburg, Florida 34748, United States
  • Atlanta Research Center
    Atlanta, Georgia 30319, United States
  • Radiant Research
    Chicago, Illinois 60602, United States
  • Radiant Research
    Bridgeton, Missouri 63044, United States
  • Radiant Research
    Papillion, Nebraska 68046, United States
  • Radiant Research
    Henderson, Nevada 89074, United States
  • Radiant Research
    Las Vegas, Nevada 89128, United States
  • New Mexico Clinical Research & Osteoporosis Center
    Albuquerque, New Mexico 87106, United States
  • Lillestol Research
    Fargo, North Dakota 58103, United States
  • Radiant Research
    Akron, Ohio 44311, United States
  • Radiant Research
    Cincinnati, Ohio 45236, United States
  • Altoona Center for Clinical Research
    Duncansville, Pennsylvania 16635, United States
  • Pennsylvania Regional Center for Arthritis & Osteoporosis Research
    Wyomissing, Pennsylvania 19610, United States
  • Radiant Research
    Dallas, Texas 75231, United States
  • Radiant Research
    Plano, Texas 75093, United States
  • Radiant Research
    San Antonio, Texas 78229, United States
  • Radiant Research
    San Antonio, Texas 78240, United States
  • Spectrum Medical
    Danville, Virginia 24541, United States
  • Radiant Research
    Puyallup, Washington 98372, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03002428
Lead sponsor
Pfenex, Inc
Responsible party
Sponsor
First posted
Dec 23, 2016
Start date
Dec 2016
Primary completion
May 2018
Completion
May 2018
Last update
May 23, 2018

Study contacts

Hubert C Chen, MD
study director · Pfenex, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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