deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03432533

A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis

A Randomized, Multicenter, Open-label, Parallel Group Study in Postmenopausal Women With Osteoporosis to Evaluate the Noninferiority of Subject-administered Romosozumab Via Autoinjector/Pen vs Healthcare Provider-administered Romosozumab Via Prefilled Syringe

Sponsor: Amgen

Conditions Post-Menopausal Osteoporosis
Interventions romosozumab HCP administration with PFS romosozumab self-administration with AI/Pen
Updated 18 times since 2018 Last updated: Nov 5, 2020 Started: Feb 6, 2018 Primary completion: Apr 11, 2019 Completion: Jan 8, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03432533, this PHASE3 trial focuses on Post-Menopausal Osteoporosis and remains completed. Sponsored by Amgen, it has been updated 18 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Oct 2018 · 2 months · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~May 2019 · 6 months · monthly snapshot~May 2019 – ~Aug 2019 · 3 months · monthly snapshot~Aug 2019 – ~Jan 2020 · 5 months · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~May 2020 · 3 months · monthly snapshot~May 2020 – ~Dec 2020 · 7 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

18 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Dec 2020 — Jan 2021 [monthly]

    Completed PHASE3

▶ Show 13 earlier versions

  1. May 2020 — Dec 2020 [monthly]

    Completed PHASE3

  2. Feb 2020 — May 2020 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Jan 2020 — Feb 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: Completed → Active Not Recruiting

  4. Aug 2019 — Jan 2020 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  5. May 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE3

  6. Nov 2018 — May 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  7. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  8. Aug 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

  9. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE3

  10. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE3

  11. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  12. Apr 2018 — May 2018 [monthly]

    Recruiting PHASE3

  13. Mar 2018 — Apr 2018 [monthly]

    Recruiting PHASE3

    First recorded

Feb 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Amgen
Data source: Amgen

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Bialystok, Poland , Birmingham, United States , Bridgeton, United States , Chandler, United States , Charlotte, United States , Chesapeake, United States , Chorley, United Kingdom , Cincinnati, United States , Cypress, United States and 34 more locations