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A Comparison of PF708 and Forteo in Osteoporosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03002428
Recruitment Status : Completed
First Posted : December 23, 2016
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Pfenex, Inc

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Teriparatide (PF708) Drug: Teriparatide (Forteo) Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study Comparing the Effects of PF708 and Forteo in Patients With Osteoporosis
Actual Study Start Date : December 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Blood levels of anti-drug antibody (ADA) against teriparatide [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002428


Locations
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Sponsors and Collaborators
Pfenex, Inc
Investigators
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Study Director: Hubert C Chen, MD Pfenex, Inc
More Information
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Responsible Party: Pfenex, Inc
ClinicalTrials.gov Identifier: NCT03002428    
Other Study ID Numbers: PF708-301
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
 Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents