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:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT07036003
Eligibility Criteria:
Inclusion Criteria:
* Between 18 - 60 years old.
* Diagnosis of isolated knee osteoarthritis for greater than 6 months.
Exclusion Criteria:
* Previous or pending surgery to involved knee.
* Previous major trauma to involved knee, or ipsilateral knee, hip, or ankle.
* Recent (less than 6 months) intra-articular injection into the involved knee.
* High grade ligamentous knee injury.
* Known allergy to recombinant human growth hormone (rHGH) or reconstitutive solutions.
* BMI of less than 20 or greater than 35.
* Documented history of growth disorder of bones or connective tissue, type 1 or 2 diabetes, myopathy, cancer, endocrine disorder, severe hypertension (SBP \> 180) or rheumatologic disorder.
* Pregnant or breastfeeding, or actively attempting to get pregnant.
* Currently on hypoglycemic therapy, oral estrogen or glucocorticoid replacement therapy.
* Would have difficulty with the self-injection schedule or other cognitive/ functional limitations.
* Vital signs or routine bloodwork outside of normal range.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07036003
Study Brief:
Protocol Section:
NCT07036003