Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05768854 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta

Study acronym: Cosmic
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv22
  2. Primary completion date changed from estimate of Mar 2026 to Oct 23, 2025v21
  3. Study sites: 21 to 20 Primary completion date: Dec 2025 to Mar 2026 · Completion date: Jun 2026 to Apr 2027 · Secondary endpoints: 7 to 9 · 1 morev20 Show 4 more changesShow less
    • Primary completion date: Dec 2025 to Mar 2026
    • Completion date: Jun 2026 to Apr 2027
    • Secondary endpoints: 7 to 9
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites revised (21)v19 See this version in full on ClinicalTrials.gov ↗
  5. Primary endpoint revised Study sites: 22 to 21 · Secondary endpoints: 5 to 7v18 Show 2 more changesShow less
    • Study sites: 22 to 21
    • Secondary endpoints: 5 to 7

    See this version in full on ClinicalTrials.gov ↗

Show 16 earlier versionsHide 16 earlier versions
  1. Re-verified, no change to tracked fieldsv17
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 66 to confirmed 69 · Site details revised at 22 of 22 sitesv16 Show 2 more changesShow less
    • Enrollment target: estimated 66 to confirmed 69
    • Site details revised at 22 of 22 sites
  3. 2 versions Re-verified since Mar 7, 2024, no change to tracked fieldsv14-v15
  4. Site details revised at 2 of 22 sitesv13
  5. Site details revised at 4 of 22 sitesv12
  6. Site details revised at 1 of 22 sitesv11
  7. Re-verified, no change to tracked fieldsv10
  8. Study sites: 21 to 22v9
  9. Site details revised at 2 of 21 sitesv8
  10. Eligibility criteria expanded, about 15 words Site details revised at 3 of 21 sites · Study title shortened, about 5 wordsv7 Show 2 more changesShow less
    • Site details revised at 3 of 21 sites
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 22 to 21v6
  12. Re-verified, no change to tracked fieldsv5
  13. Study sites: 20 to 22 Start date changed from estimate of May 2023 to Jun 14, 2023v4 Show 1 more changeShow less
    • Start date changed from estimate of May 2023 to Jun 14, 2023
  14. Study sites: 1 to 20v3
  15. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Apr 2023 to May 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Apr 2023 to May 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary objective of the study is to evaluate the effect of setrusumab vs intravenous bisphosphonates (IV-BP) on reduction in fracture rate, including morphometric vertebral fractures in pediatric participants.
Trial Details
NCT Number NCT05768854
Lead Sponsor Ultragenyx Pharmaceutical Inc
Conditions Osteogenesis Imperfecta
Enrollment 69 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov