A Comparison of PF708 and Forteo in Osteoporosis Patients

Osteoporosis Clinical Trial

Official title:

A Randomized Study Comparing the Effects of PF708 and Forteo in Patients With Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002428
• Other study ID #: PF708-301
• Status: Completed
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Pfenex, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Teriparatide (PF708)
Subcutaneous injection
• Teriparatide (Forteo)
Subcutaneous injection

Locations

Country	Name	City	State
United States	Radiant Research	Akron	Ohio
United States	New Mexico Clinical Research & Osteoporosis Center	Albuquerque	New Mexico
United States	Atlanta Research Center	Atlanta	Georgia
United States	Radiant Research	Birmingham	Alabama
United States	Radiant Research	Bridgeton	Missouri
United States	Radiant Research	Chandler	Arizona
United States	Radiant Research	Chicago	Illinois
United States	Radiant Research	Cincinnati	Ohio
United States	Radiant Research	Colorado Springs	Colorado
United States	Radiant Research	Dallas	Texas
United States	Spectrum Medical	Danville	Virginia
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Lillestol Research	Fargo	North Dakota
United States	Radiant Research	Henderson	Nevada
United States	Radiant Research	Las Vegas	Nevada
United States	OB-GYN Associates of Mid-Florida	Leesburg	Florida
United States	Radiant Research	Mesa	Arizona
United States	The Orthopaedic Group	Mobile	Alabama
United States	Radiant Research	Papillion	Nebraska
United States	SunValley Arthritis Center	Peoria	Arizona
United States	Radiant Research	Phoenix	Arizona
United States	Radiant Research	Plano	Texas
United States	Radiant Research	Puyallup	Washington
United States	Radiant Research	San Antonio	Texas
United States	Radiant Research	San Antonio	Texas
United States	Pennsylvania Regional Center for Arthritis & Osteoporosis Research	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfenex, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood levels of anti-drug antibody (ADA) against teriparatide		24 weeks
Secondary	Mean percentage change in lumbar-spine bone mineral density (BMD)		24 weeks
Secondary	Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP)		24 weeks
Secondary	Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX)		24 weeks
Secondary	Plasma maximum concentration (Cmax) of teriparatide		4 hours
Secondary	Plasma area-under-the-curve (AUC) of teriparatide		4 hours