Experimental drug for brittle bones tested in small trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.