E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with muscle wasting (atrophy) after hip fracture surgery and subsequent postsurgical rehabilitation |
|
E.1.1.1 | Medical condition in easily understood language |
Patients muscle wasting (atrophy) after hip fracture surgery |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028371 |
E.1.2 | Term | Muscular wasting and disuse atrophy, not elsewhere classified |
E.1.2 | System Organ Class | 100000004859 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020100 |
E.1.2 | Term | Hip fracture |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
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 assess change from baseline to week 24 in total lean body mass. |
|
E.2.2 | Secondary objectives of the trial |
To assess:
- Change from baseline at week 24 in gait speed.
- Change from baseline at week 24 in physical performance as measured by the Short Physical Performance Battery (SPPB)
- Safety and tolerability assessed by various measures such as vital signs, clinical laboratory variables, electrocardiogram (ECG), echocardiogram (only on patients enrolled before Amendment #3), adverse events (AE), X-ray assessment of the surgical procedure and potential orthopedic complications.
- The post treatment effect on physical performance and mobility as measured by SPPB and gait speed up to End of Study
- effects on incidence of falls |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Must have had surgical fixation or arthroplasty for a fracture of the proximal femur as confirmed by radiography;
Must be able to complete a 4 m gait speed test;
Must have completed surgical wound healing;
Must weigh at least 35 kg.
Other protocol-defined inclusion criteria may apply. |
|
E.4 | Principal exclusion criteria |
Must not have history of any other lower limb fractures in the past 6 months;
Must not have certain cardiovascular conditions
Must not have a chronic active infection (e.g. HIV, hepatitis B or C, etc);
Must not have used high-dose corticosteroid medications for at least 3 months in the past year;
Other protocol-defined exclusion criteria may apply. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline to week 24 in total lean body mass |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
A. Change from baseline to week 24 in gait speed.
B. Change from baseline to week 24 in physical performance as measured by the Short Physical Performance Battery
C. Safety and tolerability assessed by various measures such as adverse events
D. Change from baseline to week 48 in SPPB and gait speed
E. Frequency of falls |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
A & B: Baseline, week 24
C: Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 36, week 48
D: Baseline, week 24, week 36, week 48
E: Week 24 and Week 48 |
|
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
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 |
Exploratory to test tolerability, biomarkers assessments, quality of life and resource utilization assessments |
|
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 33 |
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 | No |
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 |
Argentina |
Australia |
Austria |
Belgium |
Chile |
Colombia |
Czech Republic |
France |
Germany |
Hungary |
Japan |
Mexico |
Romania |
Russian Federation |
Spain |
Switzerland |
Taiwan |
Turkey |
United Kingdom |
United States |
|
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
|
|
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 | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 2 |