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NCT01631214 · ClinicalTrials.gov registry record · Phase 3

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

A Phase 3 study, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
4,093
Enrollment target

NCT01631214 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 4,093 participants.

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The verdict

NCT01631214, a Phase 3 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
4,093 participants
Enrollment target

Study Summary

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

Interventions

  • DRUG Alendronate
  • BIOLOGICAL Romosozumab
  • DRUG Placebo to Romosozumab
  • DRUG Placebo to Alendronate

Trial Details

FieldValue
Enrollment Target 4,093 participants
Start Date 2012-05-04
Est. Completion 2017-06-29
Phase Phase 3

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT01631214

The ClinicalTrials.gov registry entry for NCT01631214 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,093 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Alendronate is the first listed.

NCT01631214 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01631214 about?

NCT01631214 is a clinical study titled "Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis". The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

What is the current status of trial NCT01631214?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,093 participants. The study started on 2012-05-04. Estimated completion is 2017-06-29.

What interventions are being tested in trial NCT01631214?

The interventions under investigation include: Alendronate (DRUG), Romosozumab (BIOLOGICAL), Placebo to Romosozumab (DRUG), Placebo to Alendronate (DRUG).

Who is sponsoring clinical trial NCT01631214?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.