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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive use of teriparatide for the healing of Jones fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide | Experimental | Patients randomized into this group will inject 20mcg of teriparatide once daily for 16 weeks or until the study endpoint is achieved. Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily. |
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| Placebo Control | Placebo Comparator | Patients randomized into this group will inject a matching dose of placebo once daily for 16 weeks or until the study endpoint is achieved. Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | 20mcg once daily for 16 weeks or until study endpoint is achieved. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fracture healing | weeks 4 through 24 after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | weeks 4 through 24 after start of treatment | |
| Range of Motion | weeks 4 through 24 after start of treatment | |
| Function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter H. Edwards, Jr., MD | Contact | 614-827-8700 | LArnott@ohio-ortho.com |
| Name | Affiliation | Role |
|---|---|---|
| Peter H. Edwards, Jr., MD | Ohio Orthopedic Center of Excellence | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio Orthopedic Center of Excellence | Recruiting | Upper Arlington | Ohio | 43220 | United States |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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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 |
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| Placebo | Drug | matching dose of 20mcg of placebo once daily for 16 weeks or until study endpoint is achieved |
|
| weeks 4 through 24 after start of treatment |
| Return to Activity | weeks 4 through 24 after start of treatment |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |