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Anti-Aging drug and football drills join forces to fight brittle bones

NCT ID NCT06789900

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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Conditions

The condition(s) this trial relates to.

Bone Diseases, Metabolic Motor Activity postmenopausal osteoporosis prevention target

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.