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Trial · NCT00529659

A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)

NCT00529659, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2012-07-02

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005). Trials, record NCT00529659. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00529659

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Trial

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

Title
A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)
NCT number
NCT00529659
Status
Completed
Phases
Phase 2
Enrollment
170 participants, actual
Lead sponsor
Merck Sharp & Dohme LLC
Conditions
Sarcopenia
Interventions
Comparator: MK-0773, Comparator: Placebo
First posted
2007-09-14
Last updated
2015-02-16
Results first posted
2012-07-02

Source ClinicalTrials.gov

Registered outcomes6

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

ListOutcomeTime frameDescription
PrimaryChange From Baseline in Participant Lean Body MassBaseline, Month 6
PrimaryChange From Baseline in Bilateral Leg Press (BLP) MeasurementBaseline, Month 6
BLP measurements were obtained with the participant sitting on the BLP exercise machine with flexed hips and knees. The participant held the handgrips with hips flexion and knees bent at a 90 degree angle and feet placed evenly on the footpad with heels placed approximately shoulder width apart. Participants were asked to slowly push the footpad forward, while keeping the knees slightly flexed, and bend back again slowly for one repetition. The BLP procedure measures the maximum amount of weight that the patient can push through his or her full range of motion one time.
SecondaryChange From Baseline in Participant Short Physical Performance Battery (SPPB)Baseline, Month 6
The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The SPPB consists of 3 types of physical maneuvers: balance test, speed gait test, and chair stand test. Results from each maneuvers test are scored on a scale of 0 to 4, with an increasing composite score indicating an improved function level. The total maximum score of SPPB is 12.
SecondaryChange From Baseline in Participant Gait SpeedBaseline, Month 6
SecondaryChange From Baseline in Stair Climbing PowerBaseline, Month 6
Stair-climbing power is an alternate measure of lower extremity muscle strength. Participants were asked to climb a standardized 4-step flight of stairs. The study coordinator timed how long it took the participant to walk up the stairs as quickly as possible. The test starts when the tester says "go" and ends when both of the patient's feet are flat on the platform area at the top of the staircase. Participants were permitted to use the railing, and/or an assistive device, if needed. Stair climbing power was calculated as = participant weight × gravity constant × height of stairs / time.
SecondaryChange From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement ScoreBaseline, Month 6
The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities, and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.

Outcomes6

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in Participant Lean Body MassBaseline, Month 6The full analysis set (FAS) included all participants that received at least one dose of the study therapy and had a post-randomization measurement of lean body mass.kgMEAN
SECONDARYChange From Baseline in Participant Short Physical Performance Battery (SPPB)Baseline, Month 6N = Number of participants with at least one non-missing measurement at the time point.Score on a ScaleMEAN
PRIMARYChange From Baseline in Bilateral Leg Press (BLP) MeasurementBaseline, Month 6N = Number of participants with at least one non-missing measurement at the time point.lbsMEAN
SECONDARYChange From Baseline in Participant Gait SpeedBaseline, Month 6N = Number of participants with at least one non-missing measurement at the time point.cm/secMEAN
SECONDARYChange From Baseline in Stair Climbing PowerBaseline, Month 6The FAS included all participants that received at least one dose of the study therapy and had a post-randomization stair climbing power measurement.wattsMEAN
SECONDARYChange From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement ScoreBaseline, Month 6N = Number of patient with at least one non-missing measurement at the time point.Score on a ScaleMEAN

Results by group14

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

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline in Participant Lean Body MassMK-07731.26Standard Deviation 1.09kg
Change From Baseline in Participant Lean Body MassPlacebo0.29Standard Deviation 1.29kg
Change From Baseline in Participant Short Physical Performance Battery (SPPB)MK-07730.92Standard Deviation 1.63Score on a Scale
Change From Baseline in Participant Short Physical Performance Battery (SPPB)Placebo0.88Standard Deviation 1.60Score on a Scale
Change From Baseline in Bilateral Leg Press (BLP) MeasurementMK-077317.42Standard Deviation 26.04lbs
Change From Baseline in Bilateral Leg Press (BLP) MeasurementPlacebo15.95Standard Deviation 27.84lbs
Change From Baseline in Participant Gait SpeedMK-07736.24Standard Deviation 17.65cm/sec
Change From Baseline in Participant Gait SpeedPlacebo8.91Standard Deviation 15.05cm/sec
Change From Baseline in Stair Climbing PowerMK-077319.68Standard Deviation 23.85watts
Change From Baseline in Stair Climbing PowerPlacebo14.98Standard Deviation 20.71watts

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDMK-077381
Overall StudySTARTEDPlacebo89
Overall StudyCOMPLETEDMK-077370
Overall StudyCOMPLETEDPlacebo66
Overall StudyNOT COMPLETEDMK-077311
Overall StudyNOT COMPLETEDPlacebo23

Adverse events322

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherNormochromic normocytic anaemiaBlood and lymphatic system disordersMK-07730810
otherNormochromic normocytic anaemiaBlood and lymphatic system disordersPlacebo1891
otherAcute myocardial infarctionCardiac disordersMK-07730810
otherAcute myocardial infarctionCardiac disordersPlacebo1891
otherAortic valve stenosisCardiac disordersMK-07730810
otherAortic valve stenosisCardiac disordersPlacebo1891
otherAtrial fibrillationCardiac disordersMK-07730810
otherAtrial fibrillationCardiac disordersPlacebo1891
otherCardiac failureCardiac disordersMK-07730810
otherCardiac failureCardiac disordersPlacebo1891

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityMK-0773
Total, all-cause mortalityPlacebo
Total, other adverse eventsMK-07735081
Total, other adverse eventsPlacebo5289
Total, serious adverse eventsMK-07731281
Total, serious adverse eventsPlacebo989

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
23732550RESULT

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 comparisons1

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

Comparison
MK-0773 vs Placebo: serious adverse events

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.

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/NCT00529659

GET https://conductscience.org/api/trials/v1/NCT00529659/events?page=2