Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bisphosphonate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Intravenous Bisphosphonates (IV-BP) -> Setrusumab | ACTIVE_COMPARATOR | Participants on IV-BP will continue their existing dose/regimen per investigator discretion; for participants not on IV-BP, the dose/regimen will be determined by the investigator. After the active-controlled period, participants will receive Setrusumab during the extension period |
| Setrusumab | EXPERIMENTAL | Participants will receive Setrusumab during the active-controlled and extension period |
| Name | Type | Description |
|---|---|---|
| Bisphosphonate | DRUG | Administered per investigator discretion via intravenous (IV) infusion |
| Setrusumab | BIOLOGICAL | A fully human sclerostin neutralizing monoclonal antibody (mAb) administered once a month (QM) via intravenous (IV) infusion |
Inclusion Criteria: * Male or female 2 to \< 7 years of age at time of informed consent * Clinical diagnosis of OI Types I, III, or IV confirmed by identification of genetic mutation in COL1A1 or COL1A2 * History of ≥ 1 fracture in the past 12 months, ≥ 2 fractures in the past 24 months, or ≥ 1 fem...
Bisphosphonate is a small molecule being studied for the treatment of Osteogenesis Imperfecta, a rare genetic bone disorder. It is currently in Phase 3 clinical development as an active-controlled therapy, meaning it is being compared against another treatment in a randomized trial.
Bisphosphonate is being developed by Ultragenyx Pharmaceutical Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RARE. The company is conducting a Phase 3 clinical trial to evaluate the drug in pediatric patients with Osteogenesis Imperfecta.
Bisphosphonate is in Phase 3 clinical development for Osteogenesis Imperfecta. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 3 trial is active but not recruiting participants, with an enrollment target of 69 patients.
Bisphosphonate is being evaluated in a Phase 3 clinical trial registered as NCT05768854, titled 'Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta.' The trial is active but not recruiting, enrolling 69 participants across the United States, Brazil, Canada, France, Italy, Netherlands, and Poland.
No, Bisphosphonate is not the same as Setrusumab. In the clinical trial NCT05768854, Setrusumab is the investigational drug being compared against bisphosphonates, which are the standard active control. Bisphosphonate is a class of drugs used to treat bone disorders, while Setrusumab is a separate investigational therapy.
The Phase 3 trial for Bisphosphonate, NCT05768854, is a randomized, active-controlled study in pediatric patients aged 2 years and older with Osteogenesis Imperfecta. It is not double-blinded and does not use a biomarker-selected patient population. The trial is enrolling 69 participants across multiple countries.