A Comparison of PF708 and Forteo in Osteoporosis Patients

Completed · Phase 3

Conditions studied: Osteoporosis

In brief

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

Key facts

Study ID

NCT03002428

Run by

Pfenex, Inc

People needed

181

Starts

2016-12-01

Expected to finish

2018-05-01

Last updated by the study team

2018-05-23

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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