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NCT00896454 · ClinicalTrials.gov registry record · Phase 2

Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium

A Phase 2 study, sponsored by Amgen.

Completed
Registry status
Phase 2
Development phase
33
Enrollment target

NCT00896454: Completed Phase 2 study, sponsored by Amgen.

NCT00896454 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00896454, a Phase 2 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 2
Development phase
33 participants
Enrollment target

Study Summary

The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium \</= 11.5 mg/dL (2.9 millimoles /L) by day 10.

Primary Outcome

Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was \< 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium \[mg/dL\] + (0.8 x (4 - serum albumin \[g/dL\]))

Interventions

  • DRUG denosumab

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2009-11-16
Est. Completion 2013-08-21
Phase Phase 2
Amgen

558 total trials

What the finished NCT00896454 record still lists

NCT00896454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 1 intervention - of which denosumab is the first listed.

NCT00896454 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00896454 about?

NCT00896454 is a clinical study titled "Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium". The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium \</= 11.5 mg/dL (2.9 millimoles /L) by day 10.

What is the current status of trial NCT00896454?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2009-11-16. Estimated completion is 2013-08-21.

What interventions are being tested in trial NCT00896454?

The interventions under investigation include: denosumab (DRUG).

Who is sponsoring clinical trial NCT00896454?

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

How this trial's enrollment target compares

Where NCT00896454's enrollment target sits among peer trials

33 1553rd of 2000 higher than 438 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 NCT00896454, the US trial registry maintained by the National Library of Medicine. NCT00896454 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.