Trials / Completed
CompletedNCT01345019
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Disease in Subjects With Newly Diagnosed Multiple Myeloma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,718 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Denosumab | Administered by subcutaneous injection once every 4 weeks. |
| DRUG | Zoledronic acid | Administered by intravenous infusion over 15 minutes once every 4 weeks |
| DRUG | Placebo to Denosumab | Administered by subcutaneous injection once every 4 weeks. |
| DRUG | Placebo to zoledronic acid | Administered by intravenous infusion over 15 minutes once every 4 weeks |
| DRUG | Denosumab (for the open-label treatment phase) | Administered by subcutaneous injection once every 4 weeks. |
Timeline
- Start date
- 2012-05-17
- Primary completion
- 2016-07-19
- Completion
- 2019-03-29
- First posted
- 2011-04-29
- Last updated
- 2022-11-08
- Results posted
- 2018-03-07
Locations
309 sites across 29 countries: United States, Australia, Austria, Bulgaria, Canada, Czechia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Lithuania, Malaysia, New Zealand, Poland, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01345019. Inclusion in this directory is not an endorsement.