Trial · NCT02152761

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

NCT02152761, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2020-08-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery. Trials, record NCT02152761. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02152761

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery
NCT number: NCT02152761
Status: Completed
Phases: Phase 2
Enrollment: 251 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Muscle Wasting (Atrophy) After Hip Fracture Surgery
Interventions: bimagrumab, placebo
First posted: 2014-06-02
Last updated: 2020-08-19
Other registries' IDs: eudract:2013-003439-31
Results first posted: 2020-08-19
Limitations and caveats: As there were no statistically significant improvements in functional measures (i.e. gait speed, SPPB) at week 24, the need to test for sustained improvement at wk 48 became irrelevant. So, wk 48 treatment differences were not evaluated

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24	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
Secondary	Change From Baseline in Gait Speed at Week 24 (Meters/Sec)	Baseline, Week 24	Mixed Model for Repeated Measures (MMRM) of change from baseline in derived gait speed (m/sec) 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 3 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 was 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
Secondary	Change From Baseline in Short Physical Performance Battery at Weeks 24	Week 24	MMRM change from baseline in total score by treatment \& visit to Week 24 in physical performance measured by Short Physical Performance Battery (SPPB) that evaluates lower extremity function. Score range is 0 (worst performance) to 12 (best) to assess dose-response relationship of bimagrumab \& facilitate adequate dose selection for future phase III studies, without need for supportive data from another dose-response finding study, at least 3 doses were required, ranging from non- or minimally effective dose to a dose where maximal efficacy was expected. Original study was initiated with only 2 doses, therefore, lower 70mg arm was added to this study, changing randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, 210mg, or 700mg. Since 70mg dose was expected to show suboptimal efficacy, fewer patients were randomized to this group \& it was used only for dose response modelling \& not hypothesis testing. Consequently, no efficacy evaluation for 70mg were performed
Secondary	Incidence of Falls up to Week 48	Up to Week 48	Group falls rate The frequency of having at least one fall up to Week 48 was summarized by treatment groups Incidence of falls was calculated for each arm up to Week 48. The ratio of these fall rates versus Placebo were calculated and presented as the Falls Rate Ratio. As mentioned in comment 5.1 above, the Falls Rate Ratio for Placebo does not apply because it would entail comparing the group to itself

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24	baseline, weeks 12 and 24	The Full Analysis Set (FAS) used for all efficacy analyses consists of all randomized patients who received at least one dose of treatment after randomization and had at least one post-dose efficacy assessment. Patients who were randomized in error were excluded. Patients were analyzed according to treatment they were assigned to at randomization.	kg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Gait Speed at Week 24 (Meters/Sec)	Baseline, Week 24	The Full Analysis Set (FAS) used for all efficacy analyses consisted of all randomized subjects who received at least 1 dose of investigational drug. Subjects were analyzed according to the treatment they were assigned to at randomization.	meters per second	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Short Physical Performance Battery at Weeks 24	Week 24	The Full Analysis Set (FAS) used for all efficacy analyses consists of all randomized patients who received at least one dose of treatment after randomization and had at least one post-dose efficacy assessment. Patients who were randomized in error were excluded. Patients were analyzed according to treatment they were assigned to at randomization.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Incidence of Falls up to Week 48	Up to Week 48	The Full Analysis Set (FAS) used for all efficacy analyses consisted of all randomized subjects who received at least one dose of investigational drug. Subjects were analyzed according to the treatment they were assigned to at randomization	Number of Falls per week	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24	Bimagrumab 700 mg	week 12	1.066	Standard Error 0.0107	kg
Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24	Bimagrumab 210 mg	week 12	1.052	Standard Error 0.0109	kg
Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24	Active Total Efficacy (AT:E)	week 12	1.059	Standard Error 0.0096	kg
Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24	Placebo	week 12	1.009	Standard Error 0.0103	kg
Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24	Bimagrumab 700 mg	week 24	1.064	Standard Error 0.0113	kg
Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24	Bimagrumab 210 mg	week 24	1.042	Standard Error 0.0115	kg
Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24	Active Total Efficacy (AT:E)	week 24	1.053	Standard Error 0.0101	kg
Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24	Placebo	week 24	0.996	Standard Error 0.0109	kg
Change From Baseline in Gait Speed at Week 24 (Meters/Sec)	Bimagrumab 700 mg		0.268	Standard Error 0.0599	meters per second
Change From Baseline in Gait Speed at Week 24 (Meters/Sec)	Bimagrumab 210 mg		0.350	Standard Error 0.0617	meters per second

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Epoch: Treatment Epoch	STARTED	Bimagrumab 700 mg	75
Epoch: Treatment Epoch	STARTED	Bimagrumab 210 mg	70
Epoch: Treatment Epoch	STARTED	Bimagrumab 70 mg	34
Epoch: Treatment Epoch	STARTED	Placebo	72
Epoch: Treatment Epoch	COMPLETED	Bimagrumab 700 mg	64
Epoch: Treatment Epoch	COMPLETED	Bimagrumab 210 mg	50
Epoch: Treatment Epoch	COMPLETED	Bimagrumab 70 mg	29
Epoch: Treatment Epoch	COMPLETED	Placebo	64
Epoch: Treatment Epoch	NOT COMPLETED	Bimagrumab 700 mg	11
Epoch: Treatment Epoch	NOT COMPLETED	Bimagrumab 210 mg	20

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events405

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	BYM338 700 mg	7	75
other	Diarrhoea	Gastrointestinal disorders	BYM338 210 mg	4	69
other	Diarrhoea	Gastrointestinal disorders	BYM338 70 mg	0	34
other	Diarrhoea	Gastrointestinal disorders	AT:S	11	178
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	72
other	Oedema peripheral	General disorders	BYM338 700 mg	9	75
other	Oedema peripheral	General disorders	BYM338 210 mg	3	69
other	Oedema peripheral	General disorders	BYM338 70 mg	1	34
other	Oedema peripheral	General disorders	AT:S	13	178
other	Oedema peripheral	General disorders	Placebo	4	72

1 to 10 of 405Source ClinicalTrials.gov

See all 405 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BYM338 700 mg	1	75
Total, all-cause mortality	BYM338 210 mg	3	69
Total, all-cause mortality	BYM338 70 mg	1	34
Total, all-cause mortality	AT:S	5	178
Total, all-cause mortality	Placebo	1	72
Total, other adverse events	BYM338 700 mg	47	75
Total, other adverse events	BYM338 210 mg	34	69
Total, other adverse events	BYM338 70 mg	15	34
Total, other adverse events	AT:S	96	178
Total, other adverse events	Placebo	30	72

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36098133	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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