Phase
Condition
N/ATreatment
Everolimus (Afinitor®)
Football Fitness Concept
Clinical Study ID
Ages 45-60 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Postmenopausal women aged 45-60 years old as evidenced by measuring serum levels ofLH 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
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, severerenal impairment (eGFR <20) or liver function (baseline phosphatase higher thantwice upper limit (105 U/L)), active rheumatic diseases, celiac disease, severechronic 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 ineverolimus 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 - plateletcount < 125,000/mm3
Patients with impaired wound healing or history of a chronic open wound
Scheduled for immunosuppressant therapy for transplant or scheduled to undergochemotherapy or any other treatment for malignancy
Untreated dyslipidemia with LDL-c > 4.9 mmol/L and family history ofdyslipidemia, Total cholesterol > 9.1 mmol/L, or triglycerides > 9.9 mmol/L
Any form of clinically relevant primary or secondary immune dysfunction ordeficiency
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 Danishand with inability to cooperate or perform physical training.
Inability to give informed consent
Study Design
Connect with a study center
Odense University Hospital
Odense, 5000
DenmarkSite Not Available


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