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

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What is this study about?

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.

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

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

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)

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark
Roskilde University Roskilde Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.09.2025

Trial locations

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.

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.

Trial ID:
2024-520372-10-00
Protocol code:
2024-520372-10-00
Trial Phase:
Therapeutic exploratory (Phase II)

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