Anti-Aging drug and football drills join forces to fight brittle bones
NCT ID NCT06789900
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a weekly dose of everolimus (a drug that targets aging pathways) and/or a fun exercise program called 'Football Fitness' can prevent the rapid bone loss that happens after menopause. 136 healthy women aged 45-60 will be assigned to one of four groups: exercise only, drug only, both, or general health advice. The main goal is to see if these interventions improve bone formation markers after 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Everolimus (a rapamycin analog) and/or structured exercise training
- What this could lead to
- If successful, this could point toward a drug-and-exercise strategy to prevent postmenopausal bone loss and reduce fracture risk.
- What could go wrong
- This is a small, early-phase trial (136 women) testing bone marker changes, not fractures. Everolimus is an immunosuppressant with side effects, and benefits may not translate to real-world fracture prevention.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
136 people
The number who actually took part.
- Started
-
Oct 2024
- Expected to finish
-
Oct 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
45 to 60 years
- Sex
-
Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Postmenopausal women aged 45-60 years old as evidenced by measuring serum levels of LH and FSH and absence of menstruation for at least 1 year. * No history of low energy hip or vertebral fractures during the last 6 months. * Ability to provide informed consent. Exclusion Criteria: * Diabetes (type 1 and 2) * Heart failure similar to NYHA Class IV * Primary hyperparathyroidism * 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 * Treatment with drugs known to affect cytochrome P450 3A due to its role in everolimus metabolism * 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 immunosuppressant 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 or perform physical training. * Inability to give informed consent
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Odense University Hospital
Odense, 5000, Denmark
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Other studies related to the condition(s) this trial covers.
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