A Comparison of PF708 and Forteo in Osteoporosis Patients

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfenex, Inc
• Treatments: Teriparatide

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