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Setrusumab vs Bisphosphonates for Osteogenesis Imperfecta (Cosmic Trial)
Phase 3
Recruiting
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
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Who is running the clinical trial?
Ultragenyx Pharmaceutical IncLead Sponsor
89 Previous Clinical Trials
178,972 Total Patients Enrolled
5 Trials studying Osteogenesis Imperfecta
306 Patients Enrolled for Osteogenesis Imperfecta
Medical DirectorStudy DirectorUltragenyx Pharmaceutical Inc
2,782 Previous Clinical Trials
8,066,250 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age requirement for participation in this clinical trial above or below thirty years?
"In accordance with the study prerequisites, participants need to be between 2 and 4 years of age in order to qualify."
Answered by AI
Has Setrusumab attained regulatory clearance from the FDA?
"There is existing evidence demonstrating the safety of Setrusumab, leading to a score of 3 on our team's scale. This medication has been through Phase 3 trials and numerous studies have backed up its efficacy."
Answered by AI
Are there still opportunities for individuals to take part in this trial?
"Verified. According to clinicaltrials.gov, this medical trial is currently recruiting participants. This study was initially posted on May 1st 2023 and has been modified as recently as May 5th 2023. It needs 66 patients from a single site for the experiment to be successful."
Answered by AI
Could I be a potential subject for this clinical experiment?
"Candidates wishing to be considered for this clinical trial must possess osteogenesis imperfecta and be aged between 2 and 4 years old. 66 patients are anticipated to take part in the study."
Answered by AI
Could you tell me how many individuals are being admitted to this experiment?
"Affirmative. According to the records available on clinicaltrials.gov, this medical trial is presently enrolling participants; it was initially advertised on 5th May 2023 and recently updated in the same month. This research project will include 66 individuals from a single site."
Answered by AI
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