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COMPLETED Phase 3

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

NCT01796301 · View on ClinicalTrials.gov ↗

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.

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

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01796301

The ClinicalTrials.gov registry entry for NCT01796301 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 436 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01796301 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Massachusetts, Buenos Aires. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01796301?

The interventions under investigation include: Teriparatide (DRUG), Romozosumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01796301?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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