Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT07085520
Eligibility Criteria:
Inclusion Criteria:
1. Signed and dated informed consent.
2. Commitment to comply with the study protocol and cooperate throughout the study.
3. Age 18-70, healthy or adult male or female with osteoarthritis combined with osteoporosis.
4. No history of skin diseases or other underlying conditions.
5. No antihistamines, vasodilators, vasoconstrictors, anticoagulants, hormones, or immunosuppressants within the past month.
6. If of childbearing age, women must have used contraception for at least one month before screening and commit to using contraception throughout the study period and for a specified time after the study ends.
Exclusion Criteria:
1. Pregnant or breastfeeding women.
2. Smoking \>10 cigarettes per day or smoking history \>20 years.
3. Presence of conditions that may interfere with the study results (e.g., severe diseases, infectious diseases, allergies, etc.) or relevant medical history.
4. Individuals receiving systemic or local treatments that affect skin homeostasis.
5. Allergic or intolerant to polyvinylpyrrolidone (PVP) or polyvinyl alcohol (PVA).
6. Contraindications for denosumab (e.g., hypocalcemia).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07085520
Study Brief:
Protocol Section:
NCT07085520