E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Closed fracture of the proximal femur |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020100 |
E.1.2 | Term | Hip fracture |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the safety of administering rhBMP-2/CPM (either 1.0 mg/mL or 2.0 mg/mL) as an adjunct to internal fixation in subjects with fractures of the proximal femur. The key safety outcome is the incidence of secondary fracture displacement among subjects treated with rhBMP-2/CPM and those receiving standard surgical treatment (internal fixation) alone. |
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E.2.2 | Secondary objectives of the trial |
To establish a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial in this clinical indication· To estimate the success and failure rates associated with key fracture outcomes |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject’s signed and dated informed consent form, approved by the institutional review board (IRB) or independent ethics committee (IEC). 2. Age ≥55 years. 3. Acute closed fracture of the proximal femur: displaced femoral neck fracture (Garden Type III or IV); basilar neck fracture (Orthopaedic Trauma Association [OTA] Classification 31-B2); or unstable intertrochanteric femur fracture (OTA Classification 31-A2 or 31-A3) 4. Anatomic reduction (open or closed) and internal fixation within 48 hours following injury using any one of the following fixation constructs: 1) multiple parallel interfragmentary screws; 2) sliding hip screw and side plate fixation; or 3) cephalomedullary nail. 5. Domestically independent (noninstitutionalized) and ambulatory (with or without walking aids) before injury. 6. Score ≥21 on Mini-Mental State Examination, indicating that subject is cognitively intact. |
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E.4 | Principal exclusion criteria |
1. Concurrent fractures of the ipsilateral or contralateral lower extremity that would impede performance on functional assessments. 2. Previous arthroplasty of contralateral hip. 3. Planned procedure(s) to stimulate fracture healing after internal fixation of the fractured hip. 4. Documented history of heterotopic ossification. 5. Pathological fractures, except if due to postmenopausal or senile osteoporosis. 6. Treatment initiated for osteoporosis within the past 16 weeks. 7. Any previous use of therapies that can be considered bone anabolic (parathyroid hormone, growth hormone, anabolic steroids, or fluoride at bone therapeutic doses) within the past year. 8. History of other metabolic bone disorders that may affect the region under study (eg, Paget’s disease, renal osteodystrophy, or benign tumor). 9. Documented history of malignancy, except basal or squamous cell carcinoma that has been fully resolved for a minimum of 5 years. 10. Retained surgical hardware in the femur under study due to previous fracture. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The efficacy data for the trial stem from clinical, radiographic, and functional assesments aimed at evaluating the key fracture outcomes of fracture healing and restoration of functional mobility. Fracture healing is determined from a combined set of clinical and radiographic criteria: absence of pain with full weight bearing and presence of radiographic fracture union. Restauration of functional mobility is assessesd by subjects' performance on the timed up and go (TUG) test, a validated method closely associated with subjects' level of independence in basic mobility |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 2 |