Treatment for Sarcopenia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA
Sarcopenia+2 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Effect of a Ghrelin Receptor Agonist on Muscle and Bone

See full description

Eligible Conditions

  • Sarcopenia
  • Osteopenia (Disorder)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 6 secondary outcomes, and 6 other outcomes in patients with Sarcopenia. Measurement will happen over the course of 12 months.

12 months
Health Aging and Body Composition-Physical Performance Battery
alanine transaminase (ALT)
appendicular lean mass (ALM)
bone mineral density of the spine and hip
fasting plasma glucose
handgrip strength
isokinetic leg strength
serum C-telopeptide (CTX)
serum aspartate transaminase (AST)
serum insulin like growth factor-1 (IGF-1)
serum procollagen 1 intact N-terminal (P1NP)
symptoms and any adverse events
total body muscle mass

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

anamorelin
1 of 2
microcrystaline cellulose
1 of 2
Active Control
Non-Treatment Group

This trial requires 32 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

microcrystaline cellulose
Drug
one identical appearing tablet daily, taken one hour before breakfast
anamorelin
Drug
one 100 mg tablet daily, taken one hour before breakfast

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Who is running the study

Principal Investigator
B. D.
Prof. Bess Dawson-Hughes, Director Bone Metabolism Lab and Professor of Medicine
Tufts University

Closest Location

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Ability to sign informed consent form
Community dwelling individuals aged 50 years and older
Men (who are sterile or agree to use contraception throughout the study)
Postmenopausal women (no menses for 5 years; early postmenopausal women are ineligible because their bone turnover rate is changing rapidly)
Sarcopenia defined as maximum grip strength <35.5 kg (men) and <20 kg (women) in either hand (excluding hands with severe pain or recent surgery) and/or gait speed <0.8 m/sec
Osteopenia defined as spine (at L1, L2, L3, or L4) or total hip or femoral neck BMD T-score between -1.0 and -2.5
Mini-mental state examination (MMSE) score >21

Patient Q&A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

There is not cost involved in participating in this trial, so insurance won't be necessary.

See if you qualify for this trial
Get access to this novel treatment for Sarcopenia by sharing your contact details with the study coordinator.