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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 : Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Estimated Study Completion Date : October 25, 2018

Resource links provided by the National Library of Medicine


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

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

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

Experimental: Bimagrumab low dose
Approximately 35 patients who meet all inclusion criteria and none of the exclusion criteria will be treated with bimagrumad low dose administered via intravenous infusion starting Day 1 until Week 20
Drug: bimagrumab
Bimagrumab will be 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 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. Compare the incidence of falls at week 24 and week 48 [ Time Frame: Baseline, Week 24, Week 48 ]
    Compare the incidence 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; Other protocol-defined inclusion and exclusion criteria may apply.


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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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: October 12, 2018
Last Verified: October 2018
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


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:
Fractures, Bone
Atrophy
Hip Fractures
Cachexia
Wasting Syndrome
Muscular Atrophy
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