deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01575834

Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME)

A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

Sponsor: Amgen

Conditions Postmenopausal Osteoporosis
Interventions Denosumab Placebo Romosozumab
Updated 20 times since 2017 Last updated: Aug 9, 2024 Started: Mar 15, 2012 Primary completion: Dec 14, 2015 Completion: Dec 28, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Postmenopausal Osteoporosis and is currently completed. Amgen leads this study, which shows 20 recorded versions since 2012 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Jun 2018 · 12 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Dec 2018 · 2 months · monthly snapshot~Dec 2018 – ~Mar 2019 · 3 months · monthly snapshot~Mar 2019 – ~Sep 2019 · 6 months · monthly snapshot~Sep 2019 – ~May 2020 · 8 months · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jan 2021 · 7 months · monthly snapshot~Jan 2021 – ~Sep 2022 · 20 months · monthly snapshot~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Mar 2024 · 14 months · monthly snapshot~Mar 2024 – ~Jun 2024 · 3 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · 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

20 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. Jun 2024 — Jul 2024 [monthly]

    Completed PHASE3

  5. Mar 2024 — Jun 2024 [monthly]

    Completed PHASE3

▶ Show 15 earlier versions

  1. Jan 2023 — Mar 2024 [monthly]

    Completed PHASE3

  2. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE3

  3. Sep 2022 — Dec 2022 [monthly]

    Completed PHASE3

  4. Jan 2021 — Sep 2022 [monthly]

    Completed PHASE3

  5. Jun 2020 — Jan 2021 [monthly]

    Completed PHASE3

  6. May 2020 — Jun 2020 [monthly]

    Completed PHASE3

  7. Sep 2019 — May 2020 [monthly]

    Completed PHASE3

  8. Mar 2019 — Sep 2019 [monthly]

    Completed PHASE3

  9. Dec 2018 — Mar 2019 [monthly]

    Completed PHASE3

  10. Oct 2018 — Dec 2018 [monthly]

    Completed PHASE3

  11. Sep 2018 — Oct 2018 [monthly]

    Completed PHASE3

  12. Jun 2018 — Sep 2018 [monthly]

    Completed PHASE3

  13. Jun 2017 — Jun 2018 [monthly]

    Completed PHASE3

  14. Feb 2017 — Jun 2017 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  15. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Mar 2012

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

Aalborg, Denmark , Akashi-shi, Japan , Albuquerque, United States , Anjyo-shi, Japan , Asheville, United States , Atugi-shi, Japan , Ballerup Municipality, Denmark , Bangalore, India , Barcelona, Spain , Barranquilla, Colombia and 173 more locations