Trial · NCT02468674
A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study
NCT02468674, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2019-12-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study. Trials, record NCT02468674. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02468674
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study
- NCT number
- NCT02468674
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 160 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Sarcopenia
- Interventions
- bimagrumab, Placebo
- First posted
- 2015-06-11
- Last updated
- 2020-06-16
- Other registries' IDs
- eudract:2015-000471-27
- Results first posted
- 2019-12-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 | Week 49 | SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function). |
| Primary | Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49 | Week 49 | SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function). |
| Secondary | Population I: 6-minute Walking Distance (6MWT) at Week 49 | Week 49 | The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition. |
| Secondary | Population II: 6-minute Walking Distance (6MWT) at Week 49 | Week 49 | The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition. |
| Secondary | Population I: Gait Speed at Week 49 | Week 49 | Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed. |
| Secondary | Population II: Gait Speed at Week 49 | Week 49 | Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed. |
| Secondary | Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 | Week 49 | ASMI is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass. |
| Secondary | Population II: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 | Week 49 | ASMI is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass. |
| Secondary | Population I: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 | Week 49 | LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect |
| Secondary | Population II: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 | Week 49 | LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 | Week 49 | The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics. | Scores on a scale | MEAN |
| PRIMARY | Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49 | Week 49 | The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics. | Scores on a scale | MEAN |
| SECONDARY | Population I: 6-minute Walking Distance (6MWT) at Week 49 | Week 49 | The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics. | meters | MEAN |
| SECONDARY | Population II: 6-minute Walking Distance (6MWT) at Week 49 | Week 49 | The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics. | meters | MEAN |
| SECONDARY | Population I: Gait Speed at Week 49 | Week 49 | The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics. | m/sec | MEAN |
| SECONDARY | Population II: Gait Speed at Week 49 | Week 49 | The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics. | m/sec | MEAN |
| SECONDARY | Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 | Week 49 | The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics. | kg/m^2 | GEOMETRIC_MEAN |
| SECONDARY | Population II: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 | Week 49 | The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics. | kg/m^2 | GEOMETRIC_MEAN |
| SECONDARY | Population I: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 | Week 49 | The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics. | kg | GEOMETRIC_MEAN |
| SECONDARY | Population II: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 | Week 49 | The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics. | kg | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 | Population I: BYM338 700 mg | 8.8 | Standard Deviation 3.86 | Scores on a scale | |
| Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 | Population I BYM338: 700 mg to Placebo | 10.2 | Standard Deviation 1.92 | Scores on a scale | |
| Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 | Population I: BYM338 210 mg | 8.0 | Standard Deviation 2.35 | Scores on a scale | |
| Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 | Population I BYM338: 210 mg to Placebo | 8.0 | Standard Deviation 2.65 | Scores on a scale | |
| Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 | Population I: BYM338 70 mg | 9.5 | Standard Deviation 2.17 | Scores on a scale | |
| Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 | Population I: BYM338 70 mg to Placebo | 7.5 | Standard Deviation 3.78 | Scores on a scale | |
| Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 | Population I: Placebo | 9.6 | Standard Deviation 1.83 | Scores on a scale | |
| Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49 | Population: II BYM338 700 mg | 8.6 | Standard Deviation 2.40 | Scores on a scale | |
| Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49 | Population: II Placebo | 8.8 | Standard Deviation 1.55 | Scores on a scale | |
| Population I: 6-minute Walking Distance (6MWT) at Week 49 | Population I: BYM338 700 mg | 318.2 | Standard Deviation 159.55 | meters |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Population I: BYM338 700 mg | 5 | |
| Overall Study | STARTED | Population I BYM338: 700 mg to Placebo | 5 | |
| Overall Study | STARTED | Population I: BYM338 210 mg | 5 | |
| Overall Study | STARTED | Population I BYM338: 210 mg to Placebo | 4 | |
| Overall Study | STARTED | Population I: BYM338 70 mg | 7 | |
| Overall Study | STARTED | Population I: BYM338 70 mg to Placebo | 7 | |
| Overall Study | STARTED | Population I: Placebo | 15 | |
| Overall Study | STARTED | Population: II BYM338 700 mg | 69 | |
| Overall Study | STARTED | Population: II Placebo | 43 | |
| Overall Study | COMPLETED | Population I: BYM338 700 mg | 4 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events585
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 | Events |
|---|---|---|---|---|---|---|
| other | Bundle branch block left | Cardiac disorders | Population I BYM338 700 mg | 0 | 5 | |
| other | Bundle branch block left | Cardiac disorders | Population I BYM338 700 mg to Placebo | 0 | 5 | |
| other | Bundle branch block left | Cardiac disorders | Population I BYM338 210 mg | 0 | 5 | |
| other | Bundle branch block left | Cardiac disorders | Population I BYM338 210 mg to Placebo | 0 | 4 | |
| other | Bundle branch block left | Cardiac disorders | Population I BYM338 70 mg | 0 | 7 | |
| other | Bundle branch block left | Cardiac disorders | Population I BYM338 70 mg to Placebo | 0 | 7 | |
| other | Bundle branch block left | Cardiac disorders | Population I Placebo | 1 | 15 | |
| other | Bundle branch block left | Cardiac disorders | Population: II BYM338 700 mg | 0 | 69 | |
| other | Bundle branch block left | Cardiac disorders | Population: II Placebo | 0 | 43 | |
| other | Ventricular extrasystoles | Cardiac disorders | Population I BYM338 700 mg | 0 | 5 |
1 to 10 of 585Source ClinicalTrials.gov
See all 585 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Population I BYM338 700 mg | 0 | 5 |
| Total, all-cause mortality | Population I BYM338 700 mg to Placebo | 0 | 5 |
| Total, all-cause mortality | Population I BYM338 210 mg | 0 | 5 |
| Total, all-cause mortality | Population I BYM338 210 mg to Placebo | 0 | 4 |
| Total, all-cause mortality | Population I BYM338 70 mg | 0 | 7 |
| Total, all-cause mortality | Population I BYM338 70 mg to Placebo | 0 | 7 |
| Total, all-cause mortality | Population I Placebo | 0 | 15 |
| Total, all-cause mortality | Population: II BYM338 700 mg | 0 | 69 |
| Total, all-cause mortality | Population: II Placebo | 0 | 43 |
| Total, other adverse events | Population I BYM338 700 mg | 4 | 5 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02468674
GET https://conductscience.org/api/trials/v1/NCT02468674/results?page=2