Clinical projects
Project title: Studies on the Effects of Age and Disease on Cellular Heterogeneity of Human Bone‑Marrow Stromal Stem Cells. The CHESS study
Purpose: The aim of this research project is to characterize the cellular heterogeneity of human bone‑marrow stromal stem cells (BMSCs) and to determine how aging, metabolic bone diseases, and clinical factors influence BMSC subpopulations. The project seeks to identify molecularly defined BMSC subtypes, understand their lineage potential, and explore their association with bone‑related diseases, ultimately laying the foundation for future integration of cell profiling into routine evaluation of patients with abnormalities in bone metabolism or osteoporosis.
Primary objective: To identify and define novel subpopulations of human BMSCs using single‑cell transcriptomics and molecular phenotyping, and determine their differentiation capacity, developmental trajectories, and senescence status.
Design: This is a multi‑phase translational research study involving up to 200 participants divided into two cohorts:
- Healthy participants: Up to 100 individuals, aged 18–80 years. Recruited from the local community.
- Patients with bone‑related conditions: Up to 100 individuals aged 18–80 years undergoing routine orthopedic surgery or diagnostic evaluation for metabolic bone diseases including osteoporosis.
Status: Ongoing
Results: Not available.
PI: Moustapha Kassem, MD, DMSc, Professor
Coordinating clinician: Shakespeare Jeromdesella, MD, PhD student
Molecular and laboratory lead: Alexander Rauch, MSc., PhD, Associate Professor
Project title: Targeting mTOR with everolimus and/or physical training for preventing postmenopausal bone loss and accelerated skeletal aging. The RapaLoad study.
Purpose: The aim of this randomised clinical trial is to test the effects of treatment with oral Everolimus, exercise, or their combination for 24 weeks as a preventive strategy for impaired musculoskeletal function in healthy postmenopausal women aged 45-60 years.
Primary outcome: Percentage change in bone formation marker P1NP (Procollagen Type 1 propeptide) between baseline and week 24.
Design: The trial will include 136 healthy women aged 45-60 years randomised to 24 weeks of treatment with one of the following regimens (1) control group getting general health advice, (2) Football fitness session group, physical training consisting of structured hybrid exercise training via the “football fitness concept” for 1hour, 2 times/week, (3) Everolimus group receiving an oral dosage of 5 mg everolimus once a week, (4) Everolimus and football fitness session group, consisting of structured hybrid exercise training via the “football fitness concept” for 1 hour, 2 times/week combined with oral Everolimus 5 mg once a week.
Status: Ongoing
Results: Not available
PI: Moustapha Kassem, MD, DMSc, professor
Primary contact: Florence Figeac, MSc, PhD, research lecturer at Odense University Hospital
Project title: SENolytics to Improve Osteoporosis therapy: A Randomised Controlled Clinical Trial. The SENIOR Trial.
Purpose: The aim of this open-label randomised clinical trial is to study osteoporosis as a disease of accelerated skeletal aging caused by accumulation of senescent cells within the skeleton and investigate the effects and safety of senolytics and antioxidant therapy on bone in men and women with increased fracture risk.
Primary outcome: Percentage change in circulating bone resorption marker CTX (C-terminal telopeptide of type I collagen) from baseline to week 20.
Design: A total of 120 participants (men and women aged 60–90 years with osteopenia or osteoporosis will be randomised 1:1:1 to 20 weeks of one of the following regimens:
- Senolytic therapy (DQ):
- Dasatinib 100 mg/day orally for 2 consecutive days
- Quercetin 1,250 mg/day orally for 3 consecutive days
- Followed by 25 days without treatment
- Repeated every 4 weeks for 5 cycles.
- Nicotinamide riboside (NR):
- NR 1 g/day orally for 20 weeks.
- Control group:
- No active treatment for 20 weeks
All participants undergo assessment of bone turnover markers, DXA, HR‑pQCT, and functional tests. Bone biopsies and marrow aspirates are collected in up to 20 participants per group.
Status: Ongoing
Results: Not available
PI: Moustapha Kassem, MD, DMSc, Professor
Primary contact: Shakespeare Jeromdesella, MD, PhD student
Project title: SHORT-term effects of GLucagon-like peptide One on BonE (SHORT-GLOBE)
Purpose: The aim of this study is to investigate the physiological effect of GLP-1 on the skeleton. We aim to elucidate how native GLP-1(7-36) regulates bone formation and resorption in healthy men and women, thus providing further insights into the effects of native GLP-1 (7-36) on human bone metabolism.
Primary outcome: Change in serum bone formation marker P1NP between baseline and day 4
Design: This is a randomized, single-blinded, crossover study that compares the biological effects of native GLP-1 (7-36) or saline on bone formation in 12 healthy individuals. Native GLP-1 (7-36) (1 pmol/kg/min) or saline will be administered subcutaneous using an insulin pump for 72 hours with a wash-out period of 18 days between exposures. The sequence of exposure is randomized.
Status: Pending
PI: Morten Svarer Hansen, MD, PhD
Primary contact: Julie Bjerrelund, MD, PhD student
Project title: The effect of oral Semaglutide on bone turnover in patients with type 2 diabetes: a randomized placebo-controlled clinical trial – (SOBER II)
Purpose: This study aims to determine if treatment with oral semaglutide or placebo (blinded allocation) for 52 weeks enhances bone formation, strength, microarchitecture and remodelling in men and women aged 50-85 with T2D.
Primary outcome: Percentage change in bone formation marker procollagen type 1 N-terminal propeptide (P1NP) after 52 weeks.
Design: A randomized, placebo-controlled, double-blinded study of the effects of 52 weeks of treatment with once daily oral GLP-1Ra semaglutide or matching placebo on bone formation. Including fasting blood samples, DXA scans and HRpQCT scans.
Status: Pending
PI: Morten Frost, MD, professor
Primary contact: Julie Bjerrelund, MD, PhD student
Project title: Resistance training and rapamycin to enhance bone formation in postmenopausal women (StrongBone)
Purpose: To test whether low-dose everolimus (Rapamycin’s analog), resistance training, or their combination enhances bone formation and muscle functions in elderly women compared to controls.
Primary outcome: Percentage change in bone formation marker (P1NP) from baseline to week 24.
Design: Randomized, two-site, placebo-controlled, 4-arm clinical trial including 148 postmenopausal women aged 60–75 years. Interventions: everolimus (5 mg weekly), placebo, resistance training (3×/week) with placebo, or resistance training with everolimus for 24 weeks.
Status: Ongoing.
Results: No results are available yet.
PI: Moustapha Kassem, MD, DMSc., professor.
Primary contact: Anna Sofie Elkjær, MD, PhD student