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Study of Everolimus and Resistance Training to Improve Bone Formation in Healthy Postmenopausal Women

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What is this trial about?

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

This study focuses on improving bone formation in healthy postmenopausal women. The research examines the effects of everolimus (also known as a rapamycin analog) combined with exercise training. Bone formation is the natural process by which the body creates new bone tissue, which is particularly important for older women who may experience bone loss after menopause.

The study will test whether taking everolimus tablets, performing resistance training (strength-building exercises), or using both approaches together can help improve bone health. Some participants will receive placebo tablets instead of the active medication. The treatment and exercise program will continue for 24 weeks.

During the study, researchers will monitor changes in bone health using various measurements, including markers of bone turnover in the blood and bone density scans. They will also assess muscle strength and overall health status. The study aims to find new ways to support bone health in postmenopausal women through the combination of medication and exercise.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment period
You will receive either everolimus (also known as rapamycin analog) tablets or placebo tablets for oral use
The treatment period will last for 24 weeks (approximately 6 months)
You will need to take the medication by mouth as prescribed
Step 2
Exercise program participation
You will participate in resistance training exercises
The exercise program will continue throughout the 24-week study period
The training will focus on improving muscle function, power, and strength in your upper and lower body
Step 3
Initial measurements
Your bone density will be measured using special X-ray equipment (DXA scan)
Blood tests will be taken to check your bone formation markers
Detailed bone structure images will be taken of your lower leg and arm using a special scanner (HRpQCT)
You will complete a health-related quality of life questionnaire (SF-12)
Step 4
Final measurements
After 24 weeks, all initial measurements will be repeated
Your bone density will be measured again
Additional blood tests will be taken
New bone structure images will be taken
You will complete the final health questionnaire

Who can join the trial?

5 criteria

Must be a woman between 60 and 75 years old of any ethnic background
Must have a bone density measurement (T-score) between less than 1.0 and greater than -2.5, measured by a special X-ray scan called DXA within 6 months before starting the study
Must be in generally good health with stable medical conditions
Must be able to understand and give informed consent, meaning the person must be mentally capable of understanding the study requirements and making decisions about participation
Must be postmenopausal (no longer having menstrual periods)

Who cannot join the trial?

15 criteria

Women who are not postmenopausal (still having menstrual periods)
Women younger than 65 years old
Having unstable medical conditions that require frequent medication changes
Active or recent cancer within the past 5 years
Having osteoporosis (a condition where bones become weak and brittle)
Taking medications that affect bone metabolism
Having conditions that prevent exercise participation
History of immunosuppression (weakened immune system)
Uncontrolled diabetes (high blood sugar levels)
Severe kidney or liver disease
Current smokers or those who quit less than 6 months ago
Regular alcohol consumption exceeding 2 drinks per day
Participation in another clinical trial within the past 30 days
Known allergies to everolimus (the study medication) or similar drugs
Major surgery planned during the study period

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Odense University Hospital
Verified
Odense, Denmark
Roskilde University
Responsive
Roskilde, Denmark

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Investigated drugs

Everolimus (also known as a rapamycin analog) is a medication that helps regulate cell growth and survival. It belongs to a class of drugs called mTOR inhibitors. In this trial, it is being studied for its potential effects on bone formation in postmenopausal women. Resistance Training is a form of physical exercise therapy that involves working against a force or weight to build strength and muscle mass. In this trial, it is being used to study its effects on bone formation and strength in postmenopausal women. The combination therapy includes both everolimus and resistance training together, which is being studied to determine if using both treatments simultaneously could provide better results for bone formation than using either treatment alone.

What is already known about the treatment

Everolimus
A synthetic derivative of rapamycin that is administered orally as a tablet and works as an immunosuppressant and anti-cancer medication. This drug functions by inhibiting the mTOR (mammalian target of rapamycin) signaling pathway, which plays a crucial role in cell growth, proliferation, and metabolism. Currently approved for treating various types of cancers and preventing organ rejection in transplant patients, it is being studied for its potential effects on bone formation in postmenopausal women. As a member of the drug class known as kinase inhibitors, everolimus represents an innovative approach in medical research for bone health management and aging-related conditions.
Rapamycin
An immunosuppressant medication administered orally that was originally discovered in soil samples from Easter Island. It works by inhibiting the mTOR pathway, which regulates cell growth and metabolism throughout the body, and is primarily used to prevent organ rejection in transplant patients. Currently being investigated for its potential anti-aging properties and effects on bone formation, this compound belongs to the macrolide class of drugs and has shown promising results in various clinical studies related to longevity and metabolic health. In medical literature, rapamycin is recognized as a versatile compound with applications extending beyond its traditional immunosuppressive role.

Investigated diseases

Osteoporosis
A condition where bones become weak and brittle due to decreased bone density and deteriorating bone structure. The body loses too much bone mass or makes too little new bone tissue, leading to an increased risk of fractures. The condition develops slowly over several years, often without noticeable symptoms in the early stages. Bone loss occurs when the creation of new bone doesn't keep up with the removal of old bone. The condition particularly affects postmenopausal women due to decreased estrogen levels.
Sarcopenia
A progressive loss of skeletal muscle mass and strength that occurs with advancing age. The condition involves the gradual loss of muscle tissue and strength that can affect daily activities. Muscle mass naturally begins to decrease between 3-8% per decade after the age of 30, with a more rapid decline after age 60. The loss of muscle mass is typically accompanied by a decrease in muscle quality and function.