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NCT01796301 · ClinicalTrials.gov registry record · Phase 3

An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women

A Phase 3 study of Postmenopausal Osteoporosis, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
436
Enrollment target
20
Study locations

NCT01796301 is a Phase 3 study of Postmenopausal Osteoporosis that has completed, run by Amgen. The registered enrollment target is 436 participants, below the 550-participant average among 12 other Postmenopausal Osteoporosis trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT01796301, a Phase 3 study of Postmenopausal Osteoporosis, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
436 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.

Conditions Studied

Postmenopausal Osteoporosis

Interventions

  • DRUG Teriparatide
  • DRUG Romozosumab

Study Locations (20)

Other

  • Research Site - Genk
  • Research Site - Ghent
  • Research Site - Leuven
  • Research Site - Liège
  • Research Site - Brno

Massachusetts

  • Research Site - Boston
  • Research Site - Boston

Buenos Aires

  • Research Site - Ciudad Autonoma de Buenos Aires
  • Research Site - Ciudad Autonoma de Buenos Aires

Ontario

  • Research Site - Toronto
  • Research Site - Toronto

Georgia

  • Research Site - Gainesville

Maryland

  • Research Site - Bethesda

Michigan

  • Research Site - Detroit

Córdoba Province

  • Research Site - Córdoba

Trial Details

FieldValue
Enrollment Target 436 participants
Start Date 2013-01-31
Est. Completion 2015-05-14
Phase Phase 3

Sponsor

Amgen

558 total trials

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What the Registry Record Tells You About NCT01796301

The ClinicalTrials.gov registry entry for NCT01796301 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 436 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 550-participant average among 12 other Postmenopausal Osteoporosis trials with a reported enrollment target (21% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Postmenopausal Osteoporosis appearing as the primary indexed condition, and to 2 interventions - of which Teriparatide is the first listed.

NCT01796301 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Massachusetts, Buenos Aires.

Frequently Asked Questions

What is clinical trial NCT01796301 about?

NCT01796301 is a clinical study titled "An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women". The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.

What is the current status of trial NCT01796301?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 436 participants. The study started on 2013-01-31. Estimated completion is 2015-05-14.

What conditions does trial NCT01796301 study?

This clinical trial studies the following conditions: Postmenopausal Osteoporosis.

What interventions are being tested in trial NCT01796301?

The interventions under investigation include: Teriparatide (DRUG), Romozosumab (DRUG).

Who is sponsoring clinical trial NCT01796301?

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

Where is trial NCT01796301 being conducted?

This trial has 20 study locations across Georgia, Maryland, Massachusetts, Michigan, Buenos Aires. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.