None listed
Conditions
Interventions
Drug, Biological/Vaccine, Non-Stem Cell : Participants who meet the inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either the test group or the control group.
The treat
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 years or older, male or female, who are either postmenopausal or willing to use appropriate contraception consistently during the study period and agree to continue contraception for up to 6 months after the last administration of the investigational product (denosumab). Acceptable methods include: for females—an intrauterine device (IUD), tubal ligation, female condom, diaphragm, etc.; for males—condom, vasectomy, etc. 2. Participants who have been receiving a GLP-1 receptor agonist (e.g., semaglutide, liraglutide, tirzepatide, etc.) for at least 3 months, or have a history of GLP-1 receptor agonist use within the past 6 months. 3. Participants who have experienced a body weight reduction of =5% compared to baseline following GLP-1 receptor agonist treatment. 4. Participants with at least one of the following risk factors for bone metabolism: ? Postmenopausal women or Men or women aged 50 years or older (-2.5 < T-score) ? Premenopausal women, or men and women under 50 years of age (Z-score = -2.0 ) 5. Participants who have voluntarily provided written informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1.Participants meeting any of the following criteria: ?Received denosumab (or its biosimilar) within 12 months prior to the screening visit. ?Received intravenous bisphosphonates (e.g., zoledronic acid) within 5 years prior to the screening visit. ?Received oral bisphosphonates (e.g., alendronate) for a cumulative duration of =3 years, or within 12 months prior to the screening visit. 2. Participants who have received prednisolone or an equivalent corticosteroid within 6 months prior to the screening visit. (However, Participants who have taken oral corticosteroids for less than 7 consecutive days at a daily dose of =5 mg prednisolone equivalent may be enrolled.) 3. Participants with a history of malignancy within 5 years prior to the screening visit. 4. Participants with moderate to severe renal impairment (eGFR 8%, or those diagnosed with type 1 diabetes mellitus. 8. Participants who are unable to maintain a stable dose of antidiabetic medications known to affect bone metabolism (e.g., thiazolidinediones [TZDs], SGLT-2 inhibitors) during the study period. 9. Participants with chronic heart failure, unstable cardiovascular disease, pulmonary disease, active tuberculosis, HIV/acquired immunodeficiency syndrome, chronic active viral hepatitis, autoimmune disease, or any other condition considered clinically significant by the investigator. 10. Participants with a history of systemic hypersensitivity to denosumab or any of its excipients, including anaphylaxis, angioedema, or urticaria. 11. Participants who are deemed unsuitable for participation in the study at the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in bone resorption marker (P-CTX) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in bone resorption marker (P-CTX);Change in bone formation marker (P-P1NP);Change in bone mineral density (BMD) at the L-Spine, Hip, or Femoral Neck;Safety assessment: adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactSoo Ryeon Lee
Ajou University Hospital
Outcome results
None listed