Study of efficacy and safety of Bimagrumab in patients after hip fracture surgery

Phase 1

Conditions: Patients with muscle wasting (atrophy) after hip fracture surgery and subsequent postsurgical rehabilitation
MedDRA version: 20.0Level: LLTClassification code 10028371Term: Muscular wasting and disuse atrophy, not elsewhere classifiedSystem Organ Class: 100000014468
MedDRA version: 20.0Level: PTClassification code 10020100Term: Hip fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-003439-31-HU

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 245

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 weigh at least 35 kg
- Must have completed surgical wound healing

Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 245

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess change from baseline to week 24 in total lean body mass.;Secondary Objective: To assess:<br>- Change from baseline at week 24 in gait speed.<br>- Change from baseline at week 24 in physical performance as measured by the Short Physical Performance Battery (SPPB)<br>- 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.<br>- The post treatment effect on physical performance and mobility as measured by SPPB and gait speed up to End of Study;Primary end point(s): Change from baseline to week 24 in total lean body mass;Timepoint(s) of evaluation of this end point: Baseline and Week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): A. Change from baseline to week 24 in gait speed<br>B. Change from baseline to week 24 in physical performance as measured by the Short Physical Performance Battery<br>C. Safety and tolerability assessed by various measures such as adverse events<br>D. Change from baseline to week 48 in SPPB and gait speed;Timepoint(s) of evaluation of this end point: A & B: Baseline, Week 24 and Week 52<br>C: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 36, Week 48<br>D: Baseline, Week 24, Week 36, Week 48