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Completed
NCT06018467
Senolytics to Improve Osteoporosis Therapy
Conditions: Osteopenia, Osteoporosis, Age-related Bone Loss
Sex: All
Ages: 60 Years – 90 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 120
Sponsor: Odense University Hospital
Location: Odense University Hospital Odense
Summary
This randomised clinical trial aims to study osteoporosis as a disease of accelerated skeletal aging caused by the accumulation of senescent cells within the skeleton and investigate the effects and safety of senolytics and antioxidant therapy on bone.
Eligibility Criteria
Inclusion Criteria:
* Men and women (menopause \> 5 years and FSH and LH in the postmenopausal range) aged 60-90 years with increased fracture risk according to WHO 10 years absolute Fracture Risk Assessment Tool (FRAX)
1. Osteopenia (ICD10 DM858A) based on a T-score ≤ -1 to -2.5 at the total hip/femoral neck, or lumbar spine, with or without a fragility fracture at any time (excluding hip and vertebral fractures within the last 2 years)
2. osteoporosis (ICD10 DM819) based on a T-score between ≥-3 and ≤ -2.5, which includes candidates suitable for conventional osteoporosis therapies, but who prefer to participate in the trial, despite being candidates for conventional osteoporosis therapy, or candidates which cannot be treated with conventional therapies due to contraindications
* Ability to provide informed consent
Exclusion Criteria:
* DXA of hip or spine not possible e.g., due to a prosthesis
* Inability to provide fasting blood samples
* Primary hyperparathyroidism
* Vitamin D deficiency (\
Source: ClinicalTrials.gov (NCT06018467). StuddyBuddy aggregates publicly available trial information.