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Study withdrawn due to staffing/enrollment related challenges.
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| Name | Class |
|---|---|
| Radius Health, Inc. | INDUSTRY |
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Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Pulsed dosing of parathyroid hormone derivatives (Forteo) has been shown to increase bone mass, and several studies in Europe have demonstrated its benefit as an adjuvant for fracture healing. Abaloparatide represents a new compound which similarly offers great potential for accelerating fracture healing, especially healing associated with callous formation. This is a randomized, double blind placebo-controlled trial to compare a group of patients being treated for supracondylar distal femur fractures who receive abaloparatide (n=38) with a control group of patients who receive a placebo (n=38).
Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Multiple methods of fixation are well accepted, and each has its own advantages and disadvantages. The common occurrence of periprosthetic supracondylar femur fractures adds another level of complexity, and the universal goal when treating these patients is to obtain and maintain acceptable alignment, allow mobilization and early weight bearing, and achieve union. To a degree, mobilization and weight bearing compete with maintenance of axial alignment, and any final outcome is a race between healing and loss of fixation. As a result, any intervention that can accelerate healing would be of great benefit. As the vast majority of these injuries heal with secondary bone healing (callous), the determination of "healing" is reliably determined using the modified Radiographic Union Score for Tibia Fractures (mRUST), and thus this patient population offers an ideal population in which to evaluate an accelerant of fracture healing.
Pulsed dosing of parathyroid hormone derivatives (Forteo) has been shown to increase bone mass, and several studies in Europe have demonstrated its benefit as an adjuvant for fracture healing. Abaloparatide represents a new compound which similarly offers great potential for accelerating fracture healing, especially healing associated with callous formation. This is a randomized, double blind placebo-controlled trial to compare a group of patients being treated for supracondylar distal femur fractures who receive abaloparatide (n=38) with a control group of patients who receive a placebo (n=38).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abaloparatide group | Experimental | Patients in the experimental group will receive abaloparatide after their surgery. |
|
| Control group | Placebo Comparator | Patients in the control group will receive a placebo after their surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abaloparatide | Drug | Abaloparatide will be dispensed as a 30-day supply of disposable pen injections of the standard, FDA approved dosage (80 mcg abaloparatide). |
|
| Measure | Description | Time Frame |
|---|---|---|
| modified Radiographic Union Score for Tibia Fractures (mRUST) | degree of callous formation and healing (worst 4 - 16 best) | 6 weeks |
| maintenance of axial alignment and loss of fixation | change in the angle between the surface and fixed implant from the baseline radiographs (taken immediately postoperative) and the radiographs taken at 6, 12, and 24 weeks postoperative | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| modified Radiographic Union Score for Tibia Fractures (mRUST) | degree of callous formation and healing (worst 4 - 16 best) | 12 weeks |
| modified Radiographic Union Score for Tibia Fractures (mRUST) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Horwitz, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| C000596789 | abaloparatide |
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| Placebo | Drug | Placebo will be dispensed as a 30-day supply of disposable pen injections. |
|
degree of callous formation and healing (worst 4 - 16 best)
| 24 weeks |
| maintenance of axial alignment and loss of fixation | change in the angle between the surface and fixed implant from the baseline radiographs | 12 weeks |
| maintenance of axial alignment and loss of fixation | change in the angle between the surface and fixed implant from the baseline radiographs | 24 weeks |