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Phase 2 Completed N=251 Randomized Quadruple-blind Treatment

Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery

Muscle Wasting (Atrophy) After Hip Fracture Surgery
Source: ClinicalTrials.gov NCT02152761 ↗
Enrolled (actual)
251
Serious AEs
21.3%
Results posted
Aug 2020
Primary outcomePrimary: 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 kg — p=<.0001

Summary

The purpose of this study was to assess if bimagrumab is safe and effective in patients with muscle wasting (atrophy) after hip fracture surgery.

Outcome Measures

OutcomeResultp-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

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;

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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