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

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ClinicalTrials.gov Identifier: NCT02152761
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Muscle Wasting (Atrophy) After Hip Fracture Surgery Drug: bimagrumab Other: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, interventional, multicenter, placebo-controlled, phase IIa/IIb trial in patients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 16, 2014
Actual Primary Completion Date : May 14, 2018
Actual Study Completion Date : October 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: bimagrumab 700 mg
Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria were treated with the bimagrumab high dose administered via intravenous infusion starting Day 1 until Week 20
Drug: bimagrumab
Bimagrumab was administered as intravenous infusion starting on Day 1 until week 20.
Other Name: BYM338

Experimental: bimagrumab 210 mg
Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria were treated with the bimagrumab medium dose administered via intravenous infusion starting Day 1 until Week 20
Drug: bimagrumab
Bimagrumab was administered as intravenous infusion starting on Day 1 until week 20.
Other Name: BYM338

Placebo Comparator: placebo
Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria received matching placbo administered via intravenous infusion starting Day 1 until Week 20
Other: placebo
Matching placebo was administered as intravenous infusion starting on Day 1 until week 20.

Experimental: Bimagrumab 70 mg
Approximately 35 patients who met all inclusion criteria and none of the exclusion criteria were treated with bimagrumad low dose administered via intravenous infusion starting Day 1 until Week 20
Drug: bimagrumab
Bimagrumab was administered as intravenous infusion starting on Day 1 until week 20.
Other Name: BYM338




Primary Outcome Measures :
  1. Change from baseline in total lean body mass measured by DXA (Dual-energy X-ray absorptiometry) at week 24 [ Time Frame: Baseline, Week 24 ]
    Change from baseline to Week 24 in total lean body mass


Secondary Outcome Measures :
  1. Change from baseline in gait speed at week 24 [ Time Frame: Baseline, Week 24 ]
    Change from baseline to Week 24 in gait speed (meters/sec)

  2. Change from baseline in short physical performance battery at week 24 [ Time Frame: Baseline, Week 24 ]
    Change from baseline to Week 24 and in physical performance as measured by the Short Physical Performance Battery

  3. Comparison the incidence of falls at week 24 versus week 48 [ Time Frame: Baseline, Week 24, Week 48 ]
    Comparison the number of falls by Week 24 and Week 48.

  4. Change from baseline in SPPB and gait speed at week 48 [ Time Frame: Baseline, week 24, week 36, week 48 ]
    Change from baseline to week 48 in SPPB and gait speed



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152761


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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02152761     History of Changes
Other Study ID Numbers: CBYM338D2201
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
bimagrumab
BYM338
hip fracture
elderly
controlled clinical trial
randomized
muscle wasting
atrophy
Additional relevant MeSH terms:
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Muscular Atrophy
Wasting Syndrome
Atrophy
Cachexia
Fractures, Bone
Hip Fractures
Wounds and Injuries
Pathological Conditions, Anatomical
Femoral Fractures
Hip Injuries
Leg Injuries
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Antibodies, Monoclonal
Antibodies, Blocking
Immunologic Factors
Physiological Effects of Drugs