A Comparison of PF708 and Forteo in Osteoporosis Patients



Status:Completed
Conditions:Osteoporosis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:30 - 85
Updated:5/25/2018
Start Date:December 2016
End Date:May 2018

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

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

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.

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
We found this trial at
25
sites
Phoenix, Arizona 85020
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Akron, Ohio 44311
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Akron, OH
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Albuquerque, NM
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Atlanta, Georgia 30319
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Atlanta, GA
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Birmingham, Alabama 35209
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Birmingham, AL
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Bridgeton, Missouri 63044
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Bridgeton, MO
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Chandler, Arizona 85225
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Chandler, AZ
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Chicago, Illinois 60654
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Chicago, IL
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Cincinnati, Ohio 45249
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Cincinnati, OH
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Colorado Springs, Colorado 80909
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Colorado Springs, CO
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Dallas, Texas 75231
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Dallas, TX
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Danville, Virginia 24541
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Danville, VA
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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Fargo, North Dakota 58103
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Fargo, ND
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Henderson, Nevada 89074
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Henderson, NV
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Las Vegas, Nevada 89146
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Las Vegas, NV
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Leesburg, Florida 34748
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Leesburg, FL
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Mesa, Arizona 85213
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Mesa, AZ
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6144 Airport Boulevard
Mobile, Alabama 36608
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Mobile, AL
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Papillion, Nebraska 68046
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Papillion, NE
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6818 West Thunderbird Road
Peoria, Arizona 85381
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Peoria, AZ
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Plano, Texas 75093
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Plano, TX
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Puyallup, Washington 98372
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Puyallup, WA
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San Antonio, Texas
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San Antonio, TX
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Wyomissing, PA
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