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Setrusumab vs Bisphosphonates for Osteogenesis Imperfecta (Cosmic Trial)
Phase 3
Waitlist Available
Research Sponsored by Ultragenyx Pharmaceutical Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Cosmic Trial Summary
This trial compares the effectiveness of two treatments for reducing fractures in children, Setrusumab and IV-BP.
Who is the study for?
This trial is for children with Osteogenesis Imperfecta (OI) types I, III, or IV who have had fractures in the past year and are currently on or have had bisphosphonate therapy. They must not have severe kidney issues, untreated hypocalcemia, a history of certain bone diseases other than OI, cardiovascular disease without clearance, or recent use of certain bone-impacting drugs.Check my eligibility
What is being tested?
The study compares setrusumab to intravenous bisphosphonates in reducing fracture rates in pediatric patients with OI. It aims to see if setrusumab is more effective at preventing new fractures including specific spinal ones.See study design
What are the potential side effects?
While the document doesn't specify side effects directly, common side effects for medications like setrusumab and bisphosphonates may include flu-like symptoms, joint pain, risk of unusual thigh bone fractures and potential jawbone problems.
Cosmic Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annualized Rate of all Radiographically-confirmed Fractures, Including Morphometric Vertebral Fractures During the Active-controlled Period
Secondary outcome measures
Annualized Rate of all Radiographically-confirmed Fractures, Excluding Morphometric Vertebral Fractures During the Active-controlled Period
Change from Baseline in Pediatric Orthopedic Society of North America Pediatric Outcomes Data Collection Instrument (POSNA-PODCI) Sports/Physical Functioning and Pain/Comfort Subscale Scores at Month 12 of the Active-controlled Period
Number of Participants With Anti-setrusumab Binding and Neutralizing Antibodies
+2 moreCosmic Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SetrusumabExperimental Treatment1 Intervention
Participants will receive Setrusumab during the active-controlled and extension period
Group II: Intravenous Bisphosphonates (IV-BP) -> SetrusumabActive Control2 Interventions
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Setrusumab, a monoclonal antibody targeting sclerostin, promotes bone growth by inhibiting a protein that normally suppresses bone formation. This is particularly beneficial for Osteogenesis Imperfecta (OI) patients, who have brittle bones due to defective collagen.
Intravenous Bisphosphonates, on the other hand, inhibit osteoclast-mediated bone resorption, leading to increased bone density and reduced bone turnover. This helps to strengthen the bones and lower the risk of fractures in OI patients.
Both treatments aim to enhance bone strength and reduce fracture rates, addressing the fundamental issue of bone fragility in OI.
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Who is running the clinical trial?
Ultragenyx Pharmaceutical IncLead Sponsor
90 Previous Clinical Trials
179,047 Total Patients Enrolled
5 Trials studying Osteogenesis Imperfecta
306 Patients Enrolled for Osteogenesis Imperfecta
Medical DirectorStudy DirectorUltragenyx Pharmaceutical Inc
2,788 Previous Clinical Trials
8,065,983 Total Patients Enrolled
4 Trials studying Osteogenesis Imperfecta
124 Patients Enrolled for Osteogenesis Imperfecta
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of spinal nerve passage narrowing not caused by scoliosis.I cannot use IV bisphosphonates as decided by my doctor.I do not have severe kidney disease or disorders affecting my bones.I have symptoms of Chiari malformation or basilar invagination, with no unstable neurologic diseases in the past 2 years.My Osteogenesis Imperfecta (Types I, III, IV) is confirmed by a genetic test.My kidney function is low, with an eGFR of 35 mL/min/1.73 m2 or less.I have had cancer in my bones or bone metastases before.I have a history of heart or blood vessel diseases.I am allergic to setrusumab or its ingredients.My vitamin D level is at least 20 ng/mL, or I've taken supplements to reach this.I have had one or more bone fractures in the last 2 years.I have or am receiving IV treatment for brittle bone disease.I have a bone condition that is not OI but causes deformity or higher fracture risk.I have never taken growth hormone, denosumab, anti-sclerostin antibody, or similar medications affecting bones.My blood calcium levels are low after fasting for at least 4 hours.I have undergone external radiation therapy before.I am between 2 and 6 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Intravenous Bisphosphonates (IV-BP) -> Setrusumab
- Group 2: Setrusumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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