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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide (PF708) | Experimental | PF708 20 mcg once-daily subcutaneous injection for 24 weeks |
|
| Teriparatide (Forteo) | Active Comparator | Forteo 20 mcg once-daily subcutaneous injection for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide (PF708) | Drug | Subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of anti-drug antibody (ADA) against teriparatide | 24 weeks |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hubert C Chen, MD | Pfenex, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Birmingham | Alabama | 35211 | United States | ||
| The Orthopaedic Group |
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| Teriparatide (Forteo) |
| Drug |
Subcutaneous injection |
|
| 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 |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Radiant Research | Chandler | Arizona | 85224 | United States |
| Radiant Research | Mesa | Arizona | 85213 | United States |
| SunValley Arthritis Center | Peoria | Arizona | 85381 | United States |
| Radiant Research | Phoenix | Arizona | 85020 | United States |
| Radiant Research | Colorado Springs | Colorado | 80909 | United States |
| OB-GYN Associates of Mid-Florida | Leesburg | Florida | 34748 | United States |
| Atlanta Research Center | Atlanta | Georgia | 30319 | United States |
| Radiant Research | Chicago | Illinois | 60602 | United States |
| Radiant Research | Bridgeton | Missouri | 63044 | United States |
| Radiant Research | Papillion | Nebraska | 68046 | United States |
| Radiant Research | Henderson | Nevada | 89074 | United States |
| Radiant Research | Las Vegas | Nevada | 89128 | United States |
| New Mexico Clinical Research & Osteoporosis Center | Albuquerque | New Mexico | 87106 | United States |
| Lillestol Research | Fargo | North Dakota | 58103 | United States |
| Radiant Research | Akron | Ohio | 44311 | United States |
| Radiant Research | Cincinnati | Ohio | 45236 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Pennsylvania Regional Center for Arthritis & Osteoporosis Research | Wyomissing | Pennsylvania | 19610 | United States |
| Radiant Research | Dallas | Texas | 75231 | United States |
| Radiant Research | Plano | Texas | 75093 | United States |
| Radiant Research | San Antonio | Texas | 78229 | United States |
| Radiant Research | San Antonio | Texas | 78240 | United States |
| Spectrum Medical | Danville | Virginia | 24541 | United States |
| Radiant Research | Puyallup | Washington | 98372 | United States |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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