Study on Everolimus to Improve Bone and Muscle Health in Elderly with Stable Conditions

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What is this study about?

This clinical trial is focused on studying the effects of the medication Everolimus on the health of elderly individuals. The study aims to see if Everolimus, which is a type of drug known as a rapamycin analog, can help prevent bone loss that comes with aging. It also looks at whether the drug can improve muscle function and reduce some of the biological processes that contribute to aging. The trial involves participants who are generally healthy elderly people with stable medical conditions.

Participants in the study will be given either Everolimus or a placebo to take orally. The study will also use Tetracycline capsules, which are another type of medication, to help with the research. The trial will last for a period of time during which participants will take the medication and undergo various assessments. These assessments will include checking changes in bone health and muscle function, as well as overall quality of life. The goal is to gather information on how Everolimus affects these aspects of health in older adults.

The study will monitor changes in specific markers in the blood that indicate bone formation and resorption, which is the process of breaking down bone tissue. It will also measure bone density and structure using special scanning techniques. Additionally, muscle strength and function will be evaluated through simple physical tests. The trial is designed to provide valuable insights into how Everolimus might be used to support healthier aging in the elderly population.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying age between 65-85 years and ensuring general good health with stable medical conditions.

Participants must not have any health conditions that could limit walking, such as a recent injury.

2 baseline measurements

Baseline measurements will be taken to assess current health status. This includes blood tests to measure bone formation and resorption markers, and scans to evaluate bone density and structure.

Muscle function, power, and strength will be assessed using a hand dynamometer, a sit-to-stand test, and gait speed measurements.

3 medication administration

Participants will be randomly assigned to receive either everolimus (5 mg tablets), tetracycline (250 mg capsules), or a placebo. All medications are taken orally.

The dosage and frequency of administration will be provided by the study team, and participants will be required to follow the instructions carefully for the duration of the study.

4 regular follow-up visits

Regular follow-up visits will be scheduled to monitor health and progress. These visits will include repeat blood tests and scans to track changes in bone and muscle health.

Participants will also complete questionnaires to assess health-related quality of life.

5 final assessment

At the end of the study, a final assessment will be conducted. This will include the same tests and measurements as the baseline to evaluate any changes.

The study is expected to conclude by September 2025, and results will be analyzed to determine the effectiveness of the treatment.

Who Can Join the Study?

Men and women aged 65-85 years old, from any ethnic background.
Be in relatively good general health, with only well-managed chronic diseases like hypertension (high blood pressure) or coronary artery disease (heart-related condition), and be clinically stable.
Participants should not have health conditions that could limit walking, such as a recent injury.

Who Cannot Join the Study?

Patients who are not generally healthy or have unstable medical conditions cannot participate.
Individuals who are not within the specified age range for the study are excluded.
Participants who are part of a vulnerable population are not eligible.
Both men and women can participate, but those who do not meet the gender criteria are excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Odense University Hospital	Odense	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.03.2024

Trial locations

Investigated drugs:

Everolimus is a medication that is being studied to see if it can help older adults maintain stronger bones and muscles as they age. It is similar to another drug called rapamycin. The researchers want to find out if everolimus can prevent bones from getting weaker and help muscles work better. They are also looking at whether it can reduce some of the biological processes that make people age. This study is focused on understanding how everolimus might help improve the overall health and vitality of elderly individuals by targeting these specific areas.

Age-related bone loss – Age-related bone loss is a condition where bones gradually lose density and strength as a person ages. This process is primarily due to an imbalance between bone resorption and bone formation, with resorption outpacing formation. As a result, bones become more fragile and susceptible to fractures. The condition often progresses silently over the years, with no symptoms until a fracture occurs. It commonly affects areas such as the spine, hips, and wrists. Regular physical activity and a balanced diet can help maintain bone health.

Trial ID:

2023-509838-19-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Everolimus to Improve Bone and Muscle Health in Elderly with Stable Conditions

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