A Comparison of PF708 and Forteo in Osteoporosis Patients

Pfenex

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Teriparatide (PF708); Drug: Teriparatide (Forteo)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03002428

PF708-301

Details and patient eligibility

About

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

Full 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.

Enrollment: 181 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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181 participants in 2 patient groups

Teriparatide (PF708)

Experimental group

Description:

PF708 20 mcg once-daily subcutaneous injection for 24 weeks

Treatment:

Drug: Teriparatide (PF708)

Teriparatide (Forteo)

Active Comparator group

Description:

Forteo 20 mcg once-daily subcutaneous injection for 24 weeks

Treatment:

Drug: Teriparatide (Forteo)