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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT05231668
Eligibility Criteria:
Inclusion Criteria:
* Participants who are clinically categorized as Type I or IV osteogenesis imperfecta with a previously documented pathogenic genetic variant in human collagen type 1 alpha 1 gene (COL1A1) or human collagen type 1 alpha 2 gene (COL1A2).
* Participants who have experienced at least 1 bone fracture in the past 10 years OR 2 or more (≥2) fractures since the age of 18.
* Body weight ≥30.0 kg.
* Contraception for sexually active male participants or female patient; not pregnant or breastfeeding; no sperm donating for male participant.
* Signed written informed assent/consent.
Exclusion Criteria:
* Previously installed rods or metal hardware that would prevent bone mineral density evaluation of the lumbar spine (note: only two of the L1-L4 vertebrae are necessary for evaluation).
* History of moderate (25-40°) to severe (\>40°) scoliosis assessed as Cobb angle (unless scoliosis does not impact assessment of bone mineral density in the lumbar vertebrae in the opinion of the investigator).
* Postmenopausal women who:
* Are within 5 years of the onset of menopause (for example less than 5 years from their last menstruation or post-hysterectomy), however if the person has been on hormone replacement therapy for more than 1 year prior to enrollment, then they are eligible regardless of time from onset of menopause. The person must be willing to continue hormone replacement therapy throughout the study duration. OR
* Were previously on hormone replacement therapy but have stopped within the past 5 years.
* History of treatment with denosumab, anti-sclerostin antibody, parathyroid hormone, bisphosphonates, or any other experimental therapy for OI within 6 months prior to any study baseline assessment.
* Known bleeding disorder.
* History of significant bleeding event that required hospitalization, surgery, or a blood transfusion that was possibly associated with increased bleeding tendency.
* Any major surgery within the last 28 days prior to investigational medicinal product (IMP) administration.
* Elective surgery or invasive procedure anticipated within 6 months after the IMP administration.
* Therapeutic doses of anticoagulants or antiplatelet agents (eg, 1 mg/kg bid of enoxaparin, 300 mg of aspirin daily, and 75 mg of clopidogrel daily or equivalent) within 7 days prior to the IMP administration.
* Any known central nervous system (CNS) or intraocular lesion that has a risk of bleeding.
* Prior history of skin cancers including melanoma, squamous cell carcinoma, or basal cell carcinoma.
* Clinically significant cardiac valvular disorder or symptomatic heart failure.
* Vitamin D (25-hydoxyvitamin D) \<15 ng/dL; rescreening will be allowed after supplementation.
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05231668
Study Brief:
Protocol Section:
NCT05231668