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NCT01406548 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density

A Phase 2 study, sponsored by Ultragenyx Pharmaceutical.

Completed
Registry status
Phase 2
Development phase
44
Enrollment target

NCT01406548 is a Phase 2 study that has completed, run by Ultragenyx Pharmaceutical. The registered enrollment target is 44 participants.

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The verdict

NCT01406548, a Phase 2 study, has completed, sponsored by Ultragenyx Pharmaceutical.

COMPLETED
Registry status
Phase 2
Development phase
44 participants
Enrollment target

Study Summary

This study is designed to provide information on the safety, tolerability, pharmacokinetics (PK) and bone biomarker response following multiple BPS804 administration in multiple dosing regimens. This information will permit a comparison of the possible risks and benefits of different dosing regimens of the study drug to enable optimal doses and dose intervals to be tested in subsequent studies.

Interventions

  • DRUG BPS804 20mg/Kg
  • DRUG Placebo to 20mg/Kg BPS804

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2011-07
Est. Completion 2013-10
Phase Phase 2

Sponsor

Ultragenyx Pharmaceutical

52 total trials

What the Registry Record Tells You About NCT01406548

The ClinicalTrials.gov registry entry for NCT01406548 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ultragenyx Pharmaceutical, which has 52 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which BPS804 20mg/Kg is the first listed.

NCT01406548 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01406548 about?

NCT01406548 is a clinical study titled "Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density". This study is designed to provide information on the safety, tolerability, pharmacokinetics (PK) and bone biomarker response following multiple BPS804 administration in multiple dosing regimens. This information will permit a comparison of the possible risks and benefits of different dosing regimens...

What is the current status of trial NCT01406548?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2011-07. Estimated completion is 2013-10.

What interventions are being tested in trial NCT01406548?

The interventions under investigation include: BPS804 20mg/Kg (DRUG), Placebo to 20mg/Kg BPS804 (DRUG).

Who is sponsoring clinical trial NCT01406548?

This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 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.