A Comparison of PF708 and Forteo in Osteoporosis Patients

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

Detailed Description
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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.

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

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide (PF708)
* Drug: Teriparatide (Forteo)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teriparatide (PF708)<br>PF708 20 mcg once-daily subcutaneous injection for 24 weeks | Drug: Teriparatide (PF708)<br>* Subcutaneous injection<br>|
| Active Comparator: Teriparatide (Forteo)<br>Forteo 20 mcg once-daily subcutaneous injection for 24 weeks | Drug: Teriparatide (Forteo)<br>* Subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of anti-drug antibody (ADA) against teriparatide |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percentage change in lumbar-spine bone mineral density (BMD) |  | 24 weeks | 
| Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP) |  | 24 weeks | 
| Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX) |  | 24 weeks | 
| Plasma maximum concentration (Cmax) of teriparatide |  | 4 hours | 
| Plasma area-under-the-curve (AUC) of teriparatide |  | 4 hours |