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

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A 24-week Double-blind Treatment and 24-week Follow-up, Randomized, Multicenter, Placebo-controlled, Phase IIa/IIb Study to Evaluate Safety and Efficacy of i.v. Bimagrumab on Total Lean Body Mass and Physical Performance in Patients After Surgical Treatment of Hip Fracture

ClinicalTrials.gov ID

NCT02152761

Acronym / sponsor ID

CBYM338D2201

Conditions

Muscle Wasting (Atrophy) After Hip Fracture Surgery

Keywords

bimagrumab, BYM338, hip fracture, elderly, controlled clinical trial, randomized, muscle wasting, atrophy

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

251 participants (actual)

Lead sponsor

Novartis PharmaceuticalsIndustry (pharma, biotech, devices)

Study start

16 Sep 2014 (actual)

Primary completion

14 May 2018 (actual)

Study completion

25 Oct 2018 (actual)

First posted

2 Jun 2014 (estimated)

Results

Posted 19 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

4

Model description

randomized, interventional, multicenter, placebo-controlled, phase IIa/IIb trial in patients

Who may qualify

Ages

60 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24

   Time frame: baseline, weeks 12 and 24

   Mixed Model for Repeated Measures (MMRM) of change from baseline in total LBM (kg) by treatment and visit To assess dose-response relationship of bimagrumab and facilitate an adequate dose selection for future phase III studies, without the need for supportive data from another dose-response finding study, at least three doses were required, ranging from a non-effective or minimally effective dose to a dose where maximal efficacy is expected. Original study was initiated with only two doses of bimagrumab, therefore, a lower dose arm of 70mg has been added to this study with Amendment 2, changing the randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, bimagrumab 210mg, or bimagrumab 700mg. Since the 70mg dose was expected to show suboptimal efficacy and fewer patients were randomized to this group, it was used only for dose response modelling and not for hypothesis testing. Consequently, no efficacy evaluations for the bimagrumab 70mg Arm were performed

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 36098133Hofbauer LC, Witvrouw R, Varga Z, Shiota N, Cremer M, Tanko LB, Rooks D, Auberson LZ, Arkuszewski M, Fretault N, Schubert-Tennigkeit AA, Papanicolaou DA, Recknor C. Bimagrumab to improve recovery after hip fracture in older adults: a multicentre, double-blind, randomised, parallel-group, placebo-controlled, phase 2a/b trial. Lancet Healthy Longev. 2021 May;2(5):e263-e274. doi: 10.1016/S2666-7568(21)00084-2.
• Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

53 sites in 19 countries: see every site and its status.