Repurposing Everolimus to enhance musculoskeletal Vitality and Ageing in The Elderly (RENOVATE)
The RENOVATE study is exploring if a medication called Everolimus, which is already approved for different uses, could also help older people maintain strong bones and muscles as they age. This is a Phase II study, which means it's an initial investigation into whether the treatment might work. Participants will be healthy older adults. They will receive either Everolimus tablets, a placebo (a dummy pill with no active ingredient), or Tetracycline capsules. Researchers will measure changes in bone health using blood tests and special scans, and assess muscle strength and overall well-being. The aim is to see if Everolimus can improve important signs linked to bone and muscle health and vitality.
At a glance
What is this study about?
The RENOVATE study (which stands for Repurposing Everolimus to enhance musculoskeletal Vitality and Ageing in The Elderly) is looking into a medication called Everolimus. This drug is already used for certain medical conditions, but researchers want to see if it could also help older, healthy adults keep their bones and muscles strong as they age. In simple terms, they are 'repurposing' the drug to see if it has other useful benefits.
Maintaining strong bones (musculoskeletal vitality) and good muscle function is really important for staying active and healthy as we get older. This study is an early-stage investigation (called Phase II), meaning it's one of the first steps to find out if Everolimus has a promising effect on these aspects of health. It's not a final recommendation, but rather a step to gather more information.
Participants in the study will be given one of three things: Everolimus tablets, a "dummy" pill (placebo) which looks like the active drug but contains no medicine, or Tetracycline capsules. This setup allows the researchers to compare the effects of Everolimus against both no treatment and another medicine. They will then carefully measure various aspects of bone and muscle health, as well as general well-being, to see if there are any positive changes.
Key takeaways
- This study explores if Everolimus can improve bone and muscle health in older adults.
- Participants will receive Everolimus, a placebo, or Tetracycline.
- It involves regular checks of bone density, muscle strength, and general health.
- The aim is to find new ways to support healthy ageing.
- It's an early-stage study, not a confirmed treatment.
- Participation includes blood tests, scans, and physical assessments.
Who may be eligible?
This study is looking for healthy older adults to take part. This means you should generally be in good health for your age, even if you have some stable, long-term medical conditions that are well-managed by your doctor.
Both men and women are welcome to participate. There are no specific age limits mentioned, meaning they are open to a wide range of older adults.
The most important thing is that you are considered to be in a stable medical condition by your healthcare team. This ensures that any changes observed during the study are likely due to the study treatment rather than other health issues.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Am I a generally healthy older adult?
- Do I have any stable long-term medical conditions?
- Am I a man or a woman (all sexes are welcome)?
- Am I interested in contributing to research on healthy ageing?
What does participation involve?
If you decide to take part in this study, you will be given either Everolimus tablets, a placebo (a dummy pill), or Tetracycline capsules to take regularly. You won't know which one you are receiving. The study involves regular visits to the clinic where you will undergo various assessments.
These assessments will include blood tests to check markers related to your bone health, such as P1NP and CTX. You will also have special scans called DXA scans to measure your bone density in areas like your spine and hips. Additionally, advanced scans (HRpQT) will be used to look at your bone structure and estimated strength in your lower leg and forearm.
Your muscle function will be tested using a hand dynamometer for grip strength, a 30-second sit-to-stand test, and by measuring your walking speed. You'll also be asked to complete a questionnaire (SF-12) to assess your general health and quality of life. The total duration of your involvement in the study, including all follow-up, will be explained to you in detail.
Potential risks and benefits
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Common questions
What is Everolimus?
Everolimus is a medication already used for some health problems, but this study is checking if it can help bone and muscle health in older adults.
What is a placebo?
A placebo is a 'dummy' pill that looks like the real medicine but contains no active ingredients. It helps researchers see if any changes are due to the treatment itself.
Why am I having scans and blood tests?
These tests help the researchers measure important signs of bone strength and health, as well as muscle function, to see if the treatment has an effect.
Will I know which treatment I'm getting?
No, in this type of study, you won't know if you're receiving Everolimus, the placebo, or Tetracycline. This is to ensure fair and accurate results.
What does 'Therapeutic exploratory (Phase II)' mean?
It means this is an early study to explore if a treatment might work and find the best ways to use it, rather than confirming it definitely works.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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