Everolimus for Age-related bone loss

Inclusion criteria

• {"criterion_text":"- Men and women aged 65-85 years old, any ethnicity"}
• {"criterion_text":"- Be in relatively good general health,(with only well-managed chronic diseases (hypertension, coronary artery disease, etc.), clinically stable"}
• {"criterion_text":"- Participants without health conditions that could limit walking (for instance recent injury)"}

Exclusion criteria

• {"criterion_text":"- Diabetes type 1 and 2"}
• {"criterion_text":"- History of coagulopathy or medical condition requiring long-term anticoagulation"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients with impaired wound healing or history of a chronic open wound"}
• {"criterion_text":"- Scheduled for immunsuppresant therapy for transplant or scheduled to undergo chemotherapy or any other treatment for malignancy"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Any form of clinically relevant primary or secondary immune dysfunction or deficiency"}
• {"criterion_text":"- Unstable ischemic heart disease"}
• {"criterion_text":"- Bone mineral density (BMD) measured by DXA scanning with T-score <-3"}
• {"criterion_text":"- Known allergy to rapamycin or rapalogs"}
• {"criterion_text":"- The study will exclude participants with inability to speak and understand Danish and with inability to cooperate"}
• {"criterion_text":"- Heart failure similar to NYHA Class IV"}
• {"criterion_text":"- Primary hyperparathyroidism"}
• {"criterion_text":"- Known vitamin D deficiency (<25 nM) (re-test after substitution acceptable)"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Previous use of bone antiresorptive or bone anabolic drugs within the last 5 years"}
• {"criterion_text":"- Use of anabolic steroids in the previous year"}
• {"criterion_text":"- Inability to give informed consent"}
• {"criterion_text":"- Treatment with drugs known to affect cytochrome P450 3A due to its role in rapamycin metabolism"}

Primary endpoints

• {"endpoint_text":"- Changes in serum bone formation marker P1NP","definition_or_measurement_approach":"Change from baseline in serum P1NP levels (serum bone formation marker)."}

Secondary endpoints

• {"endpoint_text":"- Changes in serum bone resorption marker CTX","definition_or_measurement_approach":"Change from baseline in serum CTX levels (serum bone resorption marker)."}
• {"endpoint_text":"- Changes in areal BMD at the lumbar spine, total hip and femoral neck measured by DXA scanning","definition_or_measurement_approach":"Change from baseline in areal bone mineral density at lumbar spine, total hip and femoral neck measured by DXA."}
• {"endpoint_text":"- Changes in volumetric BMD, bone microstructures and estimated strength at distal tibia and radius (HRpQT)","definition_or_measurement_approach":"Change from baseline in volumetric BMD, bone microarchitecture and estimated bone strength assessed by high-resolution peripheral quantitative tomography (HR-pQCT)."}
• {"endpoint_text":"- Changes in muscle function, power and strength for upper and lower extremities will be assessed using a standard hydraulic hand dynamometer, the 30-second sit-to-stand test (RSS), respectively and gait speed.","definition_or_measurement_approach":"Change from baseline in muscle function, power and strength assessed by hand dynamometer, 30-second sit-to-stand test (RSS) and gait speed."}
• {"endpoint_text":"- Changes in health-related quality of life assessment (SF-12 questionnaire)","definition_or_measurement_approach":"Change from baseline in SF-12 health-related quality of life questionnaire scores."}

Denmark

Earliest CTIS Part Ii Submission Date

22-02-2024

Latest Decision Or Authorization Date

24-03-2026

Processing Time Days

761

Number Of Sites

1

Number Of Participants

120

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":"1,7,8","organisation_type":"Hospital/Clinic/Other health care facility"}