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Repurposing Everolimus to enhance musculoskeletal Vitality and Ageing in The Elderly (RENOVATE)
EU CTIS ID: 2023-509838-19-00
What this study is testing
To investigate if everolimus (rapamycin analog) prevents age-related bone loss by enhancing bone formation and improving muscle functions and reducing the burden of biological mechanisms of aging in elderly persons.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men and women aged 65-85 years old, any ethnicity
- Be in relatively good general health,(with only well-managed chronic diseases (hypertension, coronary artery disease, etc.), clinically stable
- Participants without health conditions that could limit walking (for instance recent injury)
You likely can't join if
- Diabetes type 1 and 2
- History of coagulopathy or medical condition requiring long-term anticoagulation
- Anemia – Hg < 9.0 g/dl, Leukopenia – white blood cells (WBC) < 3,500/mm3 , Neutropenia absolute neutrophil count < 2,000/mm3 , or Platelet count – platelet count < 125,000/mm3
- Patients with impaired wound healing or history of a chronic open wound
- Scheduled for immunsuppresant therapy for transplant or scheduled to undergo chemotherapy or any other treatment for malignancy
- Untreated dyslipidemia with LDL-c > 4.9 mmol/L and family history of dyslipidemia, Total cholesterol > 9.1 mmol/L, or triglycerides > 9.9 mmol/L
See the full eligibility criteria
- Men and women aged 65-85 years old, any ethnicity
- Be in relatively good general health,(with only well-managed chronic diseases (hypertension, coronary artery disease, etc.), clinically stable
- Participants without health conditions that could limit walking (for instance recent injury)
- Diabetes type 1 and 2
- History of coagulopathy or medical condition requiring long-term anticoagulation
- Anemia – Hg < 9.0 g/dl, Leukopenia – white blood cells (WBC) < 3,500/mm3 , Neutropenia absolute neutrophil count < 2,000/mm3 , or Platelet count – platelet count < 125,000/mm3
- Patients with impaired wound healing or history of a chronic open wound
- Scheduled for immunsuppresant therapy for transplant or scheduled to undergo chemotherapy or any other treatment for malignancy
- Untreated dyslipidemia with LDL-c > 4.9 mmol/L and family history of dyslipidemia, Total cholesterol > 9.1 mmol/L, or triglycerides > 9.9 mmol/L
- Any form of clinically relevant primary or secondary immune dysfunction or deficiency
- Unstable ischemic heart disease
- Bone mineral density (BMD) measured by DXA scanning with T-score <-3
- Known allergy to rapamycin or rapalogs
- The study will exclude participants with inability to speak and understand Danish and with inability to cooperate
- Heart failure similar to NYHA Class IV
- Primary hyperparathyroidism
- Known vitamin D deficiency (<25 nM) (re-test after substitution acceptable)
- Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR <20) or liver function (baseline phosphatase higher than twice upper limit (105 U/L)), active rheumatic diseases, celiac disease, severe chronic obstructive lung disease (COPD), hypopituitarism, or Cushing’s disease.
- Previous use of bone antiresorptive or bone anabolic drugs within the last 5 years
- Use of anabolic steroids in the previous year
- Inability to give informed consent
- Treatment with drugs known to affect cytochrome P450 3A due to its role in rapamycin metabolism
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.