AzTrials
AzTrials

Postmenopausal WomenPhase 2RapaLoadNCT06789900

Everolimus and/or Exercise to Prevent Bone Loss in Postmenopausal Women

A Phase 2 study testing Everolimus (Afinitor®) and Football Fitness Concept in people with Postmenopausal Women, run by Odense University Hospital at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

It is estimated that women lose around 20-25% of bone mass during the 5-10 years period of postmenopausal transition, and menopause is considered a major risk factor for osteoporotic fragility fracture. Read more about this study

Who is it for?
Ages 45 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postmenopausal Women
What is being tested?
Everolimus (Afinitor®) and Football Fitness Concept
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteDenmark
Study dates
14 Oct 2024to 1 Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

About this study

Official title: Targeting mTOR With Everolimus and/or Physical Training for Preventing Postmenopausal Bone Loss and Accelerated Skeletal Aging: The RapaLoad Study

It is estimated that women lose around 20-25% of bone mass during the 5-10 years period of postmenopausal transition, and menopause is considered a major risk factor for osteoporotic fragility fracture. Currently, there is no preventive strategy to counteract these changes, and hormone replacement therapy is not considered an attractive option for many women, because of concerns related to side effects. Rapamycin, through inhibition of mTOR (the mechanistic target of Rapamycin) has been demonstrated in many preclinical animal models to extend lifespan and healthspan. The most well-established mTOR inhibitors include rapamycin (sirolimus) and its analog (also referred as rapalog). Everolimus are FDA approved and have been used for many years at a high dose as an immunosuppressant and anti-cancer drug. Exercise training has been demonstrated to counteract age-related degenerative changes in several clinical studies. The aim of this randomized clinical trial is to test the effects of treatment with oral Everolimus, exercise, or their combination as a preventive strategy for impaired musculoskeletal function in healthy postmenopausal women.

The trial will include 136 women aged 45-60 years with T-score \>-3 and no history of hip, Colles' or symptomatic vertebral fractures within the last 6 months, randomized to 24 weeks of treatment with one of the following regimens:

Read more
  1. control group getting general health advice,
  2. Football fitness session group, physical training consisting of structured hybrid exercise training via the "football fitness concept" for 1hour, 2 times/ week
  3. Everolimus group receiving an oral dosage of 5 mg everolimus once a week, (4) Everolimus and football fitness session group, consisting of structured hybrid exercise training via the "football fitness concept" for 1 hour, 2 times/week combined with oral everolimus 5 mg once a week.

The primary outcome of this trial is percentage change in bone formation marker P1NP (Procollagen Type 1 propeptide) between baseline and week 24. Secondary outcomes include percentage changes in bone resorption marker CTX (cross-lined C-telopeptide of type 1 collagen), bone mineral density (BMD), bone structure as determined by high resolution CT-scanning, muscle function and postural balance. As exploratory endpoints, changes in biological age as determined by "epigenetic clocks", levels of senescence-associated secretory phenotype (SASP) as an indicator of whole-body burden of senescent cells.

Being tested
Everolimus (Afinitor®), Football Fitness Concept
Keywords
Everolimus, Exercise, Football training session, postmenopausal women, bone loss, skeletal aging
Medical subject headings
Motor Activity, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Everolimus (Afinitor®)Drug

    Also called Football fitness session

    Oral dose of everolimus 5 mg once a week for 24 weeks

  • Football Fitness ConceptOther

    Structured hybrid exercise training via the "football fitness concept" organized as a super-vised group training at the University of Southern Denmark, Department of Sports Science and Clinical Biomechanics. "Football Fitness concept" is designed for participants with little prior experience with football and it is multifaceted training incorporating endurance training, high-intensity interval training (HIIT) and strength training. The training session lasts 60 minutes, and participants will receive two training sessions per week for 24 weeks. Each session is composed of 4 elements: a 15 min warm-up that includes strength and balance exercises, a 15 min period with technical pair-based drills, and a 30-min period with small-sided football drills

Study groups in NCT06789900
Study groupRoleWhat they receive
Control groupNo interventionParticipants will be asked to continue their life as usual with no specific recommendation
Football fitness groupExperimentalParticipants will join structured hybrid exercise training via the "football fitness concept" designed for participants with little prior experience with football and it is multifaceted training incorporating endurance training, high-intensity interval training (HIIT) and strength training. The training session lasts 60 minutes, and participants will receive two training sessions per week for 24 weeks. Each session is composed of: a 15 min warm-up that includes strength and balance exercises, a 15 min period with technical pair-based drills, and a 30-min period with small-sided football drills.
Receives: Other: Football Fitness Concept
Everolimus groupExperimentalParticipants will take an oral dose of everolimus 5 mg once a week for 24 weeks.
Receives: Drug: Everolimus (Afinitor®)
Everolimus and Football fitness groupExperimentalParticipants will join structured hybrid exercise training via the "football fitness concept" designed for participants with little prior experience with football and it is multifaceted training incorporating endurance training, high-intensity interval training (HIIT) and strength training. The training session lasts 60 minutes, and participants will receive two training sessions per week for 24 weeks. Each session is composed of: a 15 min warm-up that includes strength and balance exercises, a 15 min period with technical pair-based drills, and a 30-min period with small-sided football drills and take an oral dose of everolimus 5 mg once a week for 24 weeks.
Receives: Drug: Everolimus (Afinitor®); Other: Football Fitness Concept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procollagen type 1 N-terminal propeptide (P1NP)

    Percentage change in circulating levels of bone formation marker N-terminal fragment of procollagen type 1 (P1NP) at 24 weeks as compared with baseline

    Measured: Baseline and 24 weeks

Secondary outcomes (20)

  1. Bone resorption markers (CTX and TRAcP)

    Change in circulating levels of bone resorption markers (C-terminal telopeptide of type 1 collagen (CTX) and Tartrate resistant acid phosphatase (TRAcP))

    Measured: Baseline, week 2, week 4, week 12 and week 24

  2. Bone formation markers (Osteocalcin, bALP, P1NP (other time points))

    Change in circulating levels of bone formation markers (osteocalcin, and bone alkaline phosphatase) and additional time point for P1NP

    Measured: Baseline, week 2, week 4, week 12 and week 24 (P1NP: week 2, week 4 and week 12)

  3. Bone mineral density (BMD)

    Lumbar spine (L1-4), and total hip and femoral neck bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA)

    Measured: Baseline, week 24

  4. Bone microarchitecture, mass and geometry

    Bone microarchitecture at the distal radius and tibia assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT)

    Measured: Baseline, week 24

  5. Muscle fitness and postural balances (test 1)

    Y-balance test

    Measured: Baseline, week 24

  6. Muscle Fitness and postural balances (test 2)

    Stork balance test

    Measured: Baseline, week 24

  7. Muscle fitness and postural balances (test 3)

    Handgrip strength test

    Measured: Baseline, week 24

  8. Muscle fitness and postural balances (test 4)

    leg strength test- knee extension and knee flexion tests

    Measured: Baseline, week 24

  9. Muscle fitness and postural balances (test 5)

    Sit-to-stand chair test

    Measured: Baseline, 24 weeks

  10. Muscle fitness and postural balances (test 6)

    stair climb test

    Measured: Baseline, week 24

  11. Muscle fitness and postural balances (test 7)

    Counter Movement Jump test

    Measured: Baseline, week24

  12. Cardiopulmonary health (test 1)

    Vo2 max (seismofit)

    Measured: Baseline, week 24

  13. Cardiopulmonary health (test 2)

    Bicycle test with submaximal exercise (warm-up, submax HR and fat oxidation)

    Measured: Baseline, week 24

  14. Cardiopulmonary health (test 3)

    5-s peak power test

    Measured: Baseline, 24 weeks

  15. Cardiopulmonary health (test 4)

    maximal oxygen uptake test

    Measured: Baseline, week 24

  16. Cardiopulmonary health (test 5)

    6-min walk test

    Measured: Baseline, week 24

  17. Metabolic health (test 1)

    weight, lean and fat body mass by DXA scanning

    Measured: Baseline, week 24

  18. Metabolic health (test 2)

    Fasting blood glucose

    Measured: Baseline, week 24

  19. Metabolic health (test 3)

    Fasting insulin

    Measured: Baseline, week 24

  20. Metabolic health (test 4)

    Lipid parameters

    Measured: Baseline, week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2025
  2. Study start14 Oct 2024
  3. Primary completion1 Mar 2026
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06789900
Sponsor's protocol ID
EU CT: 2023-508093-28-00
Acronym
RapaLoad
Status last verified
Apr 2026
First submitted
27 Nov 2024
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: After completion of the project and irrespective of the outcomes, de-identified trial results will be published in peer-reviewed journals and www.clinicaltrials.gov. A summary of the clinical trial results will be presented in a language understandable to the layperson and made available in the EU database.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus (Afinitor®) and Football Fitness Concept in people with Postmenopausal Women, run by Odense University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procollagen type 1 N-terminal propeptide (P1NP) (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06789900.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in