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Resistance training and rapamycin to enhance bone formation in postmenopausal women (STRONGBONE)
EU CTIS ID: 2024-520372-10-00
What this study is testing
To investigate if treatment with everolimus (rapamycin analog), exercise training, or their combination for 24 weeks enhances bone formation in healthy postmenopausal women.
- 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
- Women aged 60-75 years old, any ethnicity
- Participants with T- score between < 1.0 and > -2.5 measured by DXA scan within 6 months of the first day of the study
- Adequate cognitive function to be able to give informed consent
- Must be able to complete 3 weekly training sessions in addition to the current training routines, without changing prior training volume or intensity
You likely can't join if
- Diabetes type 1 and 2
- Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR <30) or impaired 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
- Treatment with drugs known to affect cytochrome P450 3A due to its role in everolimus metabolism, excluding strong CYP3A4 inhibitors or inducers, while allowing weak and intermediate inhibitors or inducers. For instance Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Telithromycin, Clarithromycin, Nedazodone, Ritonavir, Atazanavir, Saquinavir, Darunavir, Indinavir, Nelfinavir, Rifampicin, Dexamethasone, Carbamazepine, phenobarbital, Phenytoin, Efavirenz and Nivirapine.
- Known medication affecting bone in the previous year
- History of coagulopathy or medical condition requiring long-term anticoagulation
See the full eligibility criteria
Who can join
- Women aged 60-75 years old, any ethnicity
- Participants with T- score between < 1.0 and > -2.5 measured by DXA scan within 6 months of the first day of the study
- Adequate cognitive function to be able to give informed consent
- Must be able to complete 3 weekly training sessions in addition to the current training routines, without changing prior training volume or intensity
What rules you out
- Diabetes type 1 and 2
- Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR <30) or impaired 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
- Treatment with drugs known to affect cytochrome P450 3A due to its role in everolimus metabolism, excluding strong CYP3A4 inhibitors or inducers, while allowing weak and intermediate inhibitors or inducers. For instance Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Telithromycin, Clarithromycin, Nedazodone, Ritonavir, Atazanavir, Saquinavir, Darunavir, Indinavir, Nelfinavir, Rifampicin, Dexamethasone, Carbamazepine, phenobarbital, Phenytoin, Efavirenz and Nivirapine.
- Known medication affecting bone in the previous year
- History of coagulopathy or medical condition requiring long-term anticoagulation
- Insufficiently treated 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
- Anemia – Hg < 5,59 mmol/L, Leukopenia – white blood cells (WBC) < 3,5 x 10⁹/L, Neutropenia absolute neutrophil count < 2,0 x 10⁹/L, or Platelet count – platelet count < 125 x 10⁹/L
- Participants 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
- Any form of clinically relevant primary or secondary immune dysfunction or deficiency
- Participants with osteoporosis (defined by DXA scan < 6 months old: low bone mass, T-score < -2.5 or hip fracture or clinical compression fracture of the spine)
- Unstable ischemic heart disease
- A potential participant should not be included if they prior to enrollment do structured strength training weekly within the past 6 months
- The study will exclude participants with inability to speak and understand Danish and with inability to cooperate
- Known allergy to rapamycin or rapalogs
- History of low energy fractures within last 6 months
- Health conditions that could limit walking and weightbearing exercise (for instance recent surgery, mobility limitation)
- Heart failure similar to NYHA Class IV
- Primary hyperparathyroidism
- Known vitamin D deficiency (<25 nM) (re-test after substitution acceptable)
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 female, 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.