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NCT01345019 · ClinicalTrials.gov registry record · Phase 3
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,718
- Enrollment target
NCT01345019: Completed Phase 3 study, sponsored by Amgen.
NCT01345019 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 1,718 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01345019, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,718 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.
Primary Outcome
A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. If there was no known event, and the participant was monitored for any one of the four SRE components, time to first on-study SR
Interventions
- DRUG Zoledronic acid
- DRUG Denosumab
- DRUG Placebo to Denosumab
- DRUG Placebo to zoledronic acid
- DRUG Denosumab (for the open-label treatment phase)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,718 participants |
| Start Date | 2012-05-17 |
| Est. Completion | 2019-03-29 |
| Phase | Phase 3 |
What the finished NCT01345019 record still lists
NCT01345019 is an interventional study that assigns participants to a tested intervention. Its 1,718 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 5 interventions - of which Zoledronic acid is the first listed.
NCT01345019 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01345019 about?
NCT01345019 is a clinical study titled "Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma". The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.
What is the current status of trial NCT01345019?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,718 participants. The study started on 2012-05-17. Estimated completion is 2019-03-29.
What interventions are being tested in trial NCT01345019?
The interventions under investigation include: Zoledronic acid (DRUG), Denosumab (DRUG), Placebo to Denosumab (DRUG), Placebo to zoledronic acid (DRUG), Denosumab (for the open-label treatment phase) (DRUG).
Who is sponsoring clinical trial NCT01345019?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01345019's enrollment target sits among peer trials
1,718 130th of 2000 higher than 1,871 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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