Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery
Muscle Wasting (Atrophy) After Hip Fracture Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02152761 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bimagrumab (Drug); placebo (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24 |
1.066; 1.052; 1.059; 1.009; 1.064; 1.042 | <.0001 sig |
| SECONDARY Change From Baseline in Gait Speed at Week 24 (Meters/Sec) |
0.268; 0.350; 0.339 | 0.1829 |
| SECONDARY Change From Baseline in Short Physical Performance Battery at Weeks 24 |
2.331; 3.535; 2.702 | 0.5802 |
| SECONDARY Incidence of Falls up to Week 48 |
0.31; 0.45; 0.36; 0.29 | 0.8353 |
Summary
Eligibility Criteria
Inclusion Criteria
Must have X-ray confirmed successful hip fracture repair; Must have completed surgical wound healing; Ability to walk a specified distance with or without a walking aid; Must weigh at least 35 kg.
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;
Data sourced from ClinicalTrials.gov (NCT02152761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.