EVEROLIMUS for Postmenopausal women | Healthy elderly women

Inclusion criteria

• {"criterion_text":"- Women aged 60-75 years old, any ethnicity\n- Participants with T- score between < 1.0 and > -2.5 measured by DXA scan within 6 months of the first day of the study\n- Adequate cognitive function to be able to give informed consent\n- Must be able to complete 3 weekly training sessions in addition to the current training routines, without changing prior training volume or intensity"}

Exclusion criteria

• {"criterion_text":"- Diabetes type 1 and 2\n- 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)\n- The study will exclude participants with inability to speak and understand Danish and with inability to cooperate\n- Known allergy to rapamycin or rapalogs\n- History of low energy fractures within last 6 months\n- Health conditions that could limit walking and weightbearing exercise (for instance recent surgery, mobility limitation)\n- Heart failure similar to NYHA Class IV\n- Primary hyperparathyroidism\n- Known vitamin D deficiency (<25 nM) (re-test after substitution acceptable)\n- 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.\n- Previous use of bone antiresorptive or bone anabolic drugs within the last 5 years\n- 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.\n- Known medication affecting bone in the previous year\n- History of coagulopathy or medical condition requiring long-term anticoagulation\n- 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\n- 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\n- Participants with impaired wound healing or history of a chronic open wound\n- Scheduled for immunosuppressant therapy for transplant or scheduled to undergo chemotherapy or any other treatment for malignancy\n- Any form of clinically relevant primary or secondary immune dysfunction or deficiency\n- Unstable ischemic heart disease\n- A potential participant should not be included if they prior to enrollment do structured strength training weekly within the past 6 months"}

Primary endpoints

• {"endpoint_text":"- Percentage change in circulating levels of bone formation marker N-terminal fragment of procollagen type 1 (P1NP) at 24 weeks as compared with baseline","definition_or_measurement_approach":"Percentage change in circulating P1NP comparing values at baseline and at 24 weeks."}

Secondary endpoints

• {"endpoint_text":"- Change in circulating levels of bone turnover marker: C-terminal telopeptide of type 1 collagen (CTX) at baseline and 24 weeks","definition_or_measurement_approach":"Change in circulating CTX measured at baseline and at 24 weeks."}
• {"endpoint_text":"- Changes in areal BMD at the lumbar spine (L1-4), total hip and femoral neck measured by dual energy x-ray absorptiometry DXA at baseline and 24 weeks","definition_or_measurement_approach":"Areal bone mineral density by DXA at lumbar spine (L1-4), total hip and femoral neck at baseline and 24 weeks."}
• {"endpoint_text":"- Changes in volumetric BMD, mass, bone microstructures and estimated strength at distal tibia and radius assessed using high resolution peripheral quantitative computed tomography (HRpQCT) at baseline and 24 weeks","definition_or_measurement_approach":"Volumetric BMD, bone microstructure and estimated strength at distal tibia and radius by HR-pQCT at baseline and 24 weeks."}
• {"endpoint_text":"- Changes in muscle function, power and strength for upper and lower extremities will be assessed using","definition_or_measurement_approach":"Assessment of muscle function, power and strength for upper and lower extremities (specific assessment tools not specified in the record)."}
• {"endpoint_text":"- Changes in health-related quality of life assessment (SF-12 questionnaire)","definition_or_measurement_approach":"Change in SF-12 questionnaire scores from baseline to 24 weeks."}

Methods

• Posters and printed recruitment materials at study sites (documents titled 'Poster StrongBone Bispebjerg' and 'Poster StrongBone Odense'). Target audience: postmenopausal women; country: Denmark (Bispebjerg and Odense sites).
• Recruitment materials with QR codes linking to study information (documents: 'Recruitment material Odense to QR code', 'Recruitment material Bispebjerg to QR code').
• Site-specific recruitment arrangements and investigator photos used in materials (documents: 'Pictures of investigators Odense', 'Recruitment material Odense', 'Recruitment material Bispebjerg').

Denmark

Earliest CTIS Part Ii Submission Date

03-07-2025

Latest Decision Or Authorization Date

24-03-2026

Processing Time Days

264

Number Of Sites

2

Number Of Participants

148

Primary sponsor

Full Name

Odense University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"codes: 1, 8","organisation_type":"Hospital/Clinic/Other health care facility"}