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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: Completed Phase 2 study, sponsored by Ultragenyx Pharmaceutical.

NCT01406548 is a Phase 2 study that has completed, run by Ultragenyx Pharmaceutical. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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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
Ultragenyx Pharmaceutical

52 total trials

What the finished NCT01406548 record still lists

NCT01406548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).

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

NCT01406548 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01406548's enrollment target sits among peer trials

44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01406548, the US trial registry maintained by the National Library of Medicine. NCT01406548 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.