Clinical trial NCT03002428: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: Pfenex, Inc
Sponsor class: INDUSTRY
First posted: 2016-12-23
Enrollment: 181
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Blood levels of anti-drug antibody (ADA) against teriparatide
timeFrame: 24 weeks
Secondary outcomes:
measure: Mean percentage change in lumbar-spine bone mineral density (BMD)
timeFrame: 24 weeks
measure: Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP)
timeFrame: 24 weeks
measure: Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX)
timeFrame: 24 weeks
measure: Plasma maximum concentration (Cmax) of teriparatide
timeFrame: 4 hours
measure: Plasma area-under-the-curve (AUC) of teriparatide
timeFrame: 4 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Mobile
country: United States
facility: The Orthopaedic Group
state: Alabama
city: Chandler
country: United States
facility: Radiant Research
state: Arizona
city: Mesa
country: United States
facility: Radiant Research
state: Arizona
city: Peoria
country: United States
facility: SunValley Arthritis Center
state: Arizona
city: Phoenix
country: United States
facility: Radiant Research
state: Arizona
city: Colorado Springs
country: United States
facility: Radiant Research
state: Colorado
city: Leesburg
country: United States
facility: OB-GYN Associates of Mid-Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta Research Center
state: Georgia
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
city: Bridgeton
country: United States
facility: Radiant Research
state: Missouri
city: Papillion
country: United States
facility: Radiant Research
state: Nebraska
city: Henderson
country: United States
facility: Radiant Research
state: Nevada
city: Las Vegas
country: United States
facility: Radiant Research
state: Nevada
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center
state: New Mexico
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Akron
country: United States
facility: Radiant Research
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pennsylvania Regional Center for Arthritis & Osteoporosis Research
state: Pennsylvania
city: Dallas
country: United States
facility: Radiant Research
state: Texas
city: Plano
country: United States
facility: Radiant Research
state: Texas
city: San Antonio
country: United States
facility: Radiant Research
state: Texas
city: San Antonio
country: United States
facility: Radiant Research
state: Texas
city: Danville
country: United States
facility: Spectrum Medical
state: Virginia
city: Puyallup
country: United States
facility: Radiant Research
state: Washington
Study officials:
affiliation: Pfenex, Inc
name: Hubert C Chen, MD
role: STUDY_DIRECTOR
References: