Recruiting

Study on Everolimus and Exercise to Prevent Bone Loss in Healthy Postmenopausal Women

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Everolimus and physical exercise on bone health in healthy postmenopausal women. Postmenopausal women are those who have stopped having menstrual periods, typically due to age. The study aims to see if Everolimus, exercise, or a combination of both can help improve bone formation and prevent bone loss, which is a common concern after menopause.

The purpose of the study is to determine if these treatments can enhance bone formation over a period of 24 weeks. Participants will be divided into groups to receive either Everolimus, engage in physical training, or both. The study will monitor changes in bone health by measuring specific markers in the blood that indicate bone formation and turnover. Additionally, bone density will be assessed using a special type of X-ray called DXA, and bone structure will be examined using a detailed imaging technique known as HR-pQCT.

Throughout the study, other health aspects such as muscle function, balance, heart and lung health, and metabolic health will also be evaluated. This includes checking weight, body composition, and blood sugar levels. The study will last for 24 weeks, with assessments conducted at the beginning, during, and at the end of the study period to track any changes in these health indicators.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to provide informed consent, confirming your understanding and agreement to participate in the trial.
Step 2
Initial assessments
At the beginning of the study, initial assessments will be conducted. These include measuring your bone mineral density using a technique called dual-energy X-ray absorptiometry (DXA), which helps assess bone health.
Your bone microarchitecture, mass, and geometry will be evaluated at specific sites using high-resolution peripheral quantitative computed tomography (HR-pQCT).
Muscle function and postural balance will be tested, and your cardiopulmonary health will be estimated by measuring your maximum oxygen uptake (Vo2max).
Metabolic health assessments will include measuring your weight, body composition, fasting blood glucose, fasting insulin, and lipid parameters.
Step 3
Medication and/or exercise
You may be assigned to receive the medication everolimus, which is taken orally. The dosage and frequency will be provided by the study team.
Alternatively, or in combination, you may participate in a physical training program designed to enhance bone formation.
The treatment or exercise program will last for a duration of 24 weeks.
Step 4
Ongoing assessments
Throughout the study, ongoing assessments will be conducted at various intervals, including at 4, 12, and 24 weeks.
These assessments will involve measuring changes in bone turnover markers, which are substances in your blood that indicate bone formation and resorption.
Additional assessments will include repeating the initial tests for bone density, bone microarchitecture, muscle function, cardiopulmonary health, and metabolic health.
Step 5
Completion of the study
At the end of the 24-week period, final assessments will be conducted to evaluate the effects of the treatment or exercise program.
The primary focus will be on the percentage change in a specific bone formation marker compared to the beginning of the study.

Who can join the trial?

3 criteria

Postmenopausal women aged 45-60 years old. This means women who have stopped having menstrual periods for at least 1 year.
No history of low energy hip or vertebral fractures in the last 6 months. This means you haven't had a bone break from a minor fall or bump in the past 6 months.
Ability to provide informed consent. This means you understand the study and agree to participate.

Who cannot join the trial?

4 criteria

Participants must be healthy postmenopausal women. This means women who have gone through menopause and do not have any significant health issues.
Participants must be within a specific age range, which is typically defined in the study but not specified here.
Men cannot participate in this study.
Individuals who are considered part of a vulnerable population are not eligible. This term generally refers to groups who may have limited ability to give informed consent or are at higher risk of harm.

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Verified sites

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Odense University Hospital
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Odense, Denmark

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Investigated drugs

Everolimus is a medication that is being studied to see if it can help prevent bone loss in postmenopausal women. It works by targeting a specific pathway in the body that is involved in cell growth and aging. In this study, researchers want to find out if everolimus can help improve bone health and slow down the aging process of the skeleton.

Physical training is another approach being tested in this study. It involves a structured exercise program designed to strengthen bones and improve overall physical health. The goal is to see if regular exercise can help maintain bone density and prevent bone loss in postmenopausal women.

Everolimus

What is already known about the treatment

Everolimus – Everolimus is administered orally in the form of tablets. It is currently being studied for its potential to prevent bone loss and slow down skeletal aging in healthy postmenopausal women. The main therapeutic indication being explored is its ability to enhance bone formation. At the molecular level, everolimus works by inhibiting a protein called mTOR, which plays a role in cell growth and metabolism. It is classified as an mTOR inhibitor in pharmacology.

Investigated diseases

Healthy – This is a state of complete physical, mental, and social well-being, not merely the absence of disease or infirmity. In a healthy individual, all bodily systems function optimally, allowing for normal growth, development, and daily activities. The body maintains homeostasis, effectively responding to environmental changes and stressors. Healthy individuals typically have balanced energy levels, good muscle function, and stable metabolic health. They exhibit normal bone density and structure, with efficient bone turnover processes. Cardiopulmonary health is robust, supporting adequate oxygen delivery and physical endurance.