Trial · NCT01345019
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
NCT01345019, Phase 3, Completed, Amgen; results first posted 2018-03-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma. Trials, record NCT01345019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01345019
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
- NCT number
- NCT01345019
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,718 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Cancer, Hematologic Malignancies, Multiple Myeloma, Oncology, Bone Metastases, Multiple Myeloma Bone Lesions
- Interventions
- Denosumab, Zoledronic acid, Placebo to Denosumab, Placebo to zoledronic acid, Denosumab (for the open-label treatment phase)
- First posted
- 2011-04-29
- Last updated
- 2022-11-08
- Other registries' IDs
- eudract:2010-020454-34
- Results first posted
- 2018-03-07
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First On-study Skeletal Related Event | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. | 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 SRE was censored at the end of the treatment phase date or the primary analysis data cut-off date, whichever came first. |
| Primary | Percentage of Participants With an On-study Skeletal Related Event | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. | 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. |
| Primary | Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. The Kaplan-Meier estimate at weeks 25, 49 and 109 is reported. | 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. |
| Secondary | Time to First On-study Skeletal Related Event - Superiority Analysis | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. | 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 SRE was censored at the end of the treatment phase date or the primary analysis data cut-off date, whichever came first. |
| Secondary | Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. | 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. Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE. A multiple event analysis was used, which accounts for both the absolute number of SREs and for the time between two consecutive events, and therefore, provides a more sensitive assessment of the risk of experiencing an SRE. The average number of events per patient is reported. |
| Secondary | Time to First and Subsequent On-Study Skeletal Related Event - Number of Events | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. | 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. Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE. A multiple event analysis was used, which accounts for both the absolute number of SREs and for the time between two consecutive events, and therefore, provides a more sensitive assessment of the risk of experiencing an SRE. The total number of events is reported. |
| Secondary | Overall Survival | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. | Overall survival was defined as the time interval (in days) from the randomization date to the date of death. If a participant was still alive at the primary analysis data cut-off date or was lost to follow-up by the primary analysis data cut-off date, survival time was censored at their last contact date or the primary analysis data cut-off date, whichever was first. |
| Secondary | Percentage of Participants Who Died | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First On-study Skeletal Related Event | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. | All randomized participants | days | MEDIAN |
| PRIMARY | Percentage of Participants With an On-study Skeletal Related Event | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. | All randomized participants | percentage of participants | NUMBER |
| PRIMARY | Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. The Kaplan-Meier estimate at weeks 25, 49 and 109 is reported. | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Time to First On-study Skeletal Related Event - Superiority Analysis | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. | All randomized participants | days | MEDIAN |
| SECONDARY | Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. | All randomized participants | events/patient | NUMBER |
| SECONDARY | Time to First and Subsequent On-Study Skeletal Related Event - Number of Events | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. | All randomized participants | skeletal-related events | NUMBER |
| SECONDARY | Overall Survival | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. | All randomized participants | days | MEDIAN |
| SECONDARY | Percentage of Participants Who Died | From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. | All randomized participants | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First On-study Skeletal Related Event | Zoledronic Acid | 730.0 | 95% Confidence Interval 504.0 to 1014.0 | days | |
| Time to First On-study Skeletal Related Event | Denosumab | 695.0 | 95% Confidence Interval 448.0 to NA | days | |
| Percentage of Participants With an On-study Skeletal Related Event | Zoledronic Acid | 44.6 | 95% Confidence Interval 41.3 to 47.9 | percentage of participants | |
| Percentage of Participants With an On-study Skeletal Related Event | Denosumab | 43.8 | 95% Confidence Interval 40.5 to 47.1 | percentage of participants | |
| Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event | Zoledronic Acid | At Week 25 | 36.5 | 95% Confidence Interval 33.3 to 39.9 | percentage of participants |
| Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event | Denosumab | At Week 25 | 35.9 | 95% Confidence Interval 32.7 to 39.3 | percentage of participants |
| Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event | Zoledronic Acid | At Week 49 | 43.2 | 95% Confidence Interval 39.7 to 46.8 | percentage of participants |
| Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event | Denosumab | At Week 49 | 43.7 | 95% Confidence Interval 40.2 to 47.3 | percentage of participants |
| Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event | Zoledronic Acid | At Week 109 | 50.6 | 95% Confidence Interval 46.6 to 54.6 | percentage of participants |
| Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event | Denosumab | At Week 109 | 50.5 | 95% Confidence Interval 46.6 to 54.5 | percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Blinded Treatment Phase | STARTED | Zoledronic Acid | 859 | |
| Blinded Treatment Phase | STARTED | Denosumab | 859 | |
| Blinded Treatment Phase | Received Treatment | Zoledronic Acid | 852 | |
| Blinded Treatment Phase | Received Treatment | Denosumab | 850 | |
| Blinded Treatment Phase | COMPLETED | Zoledronic Acid | 541 | |
| Blinded Treatment Phase | COMPLETED | Denosumab | 555 | |
| Blinded Treatment Phase | NOT COMPLETED | Zoledronic Acid | 318 | |
| Blinded Treatment Phase | NOT COMPLETED | Denosumab | 304 | |
| Open Label Treatment Phase | STARTED | Zoledronic Acid | 418 | |
| Open Label Treatment Phase | STARTED | Denosumab | 426 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events2,992
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | DB: Zoledronic Acid | 185 | 852 | |
| other | Anaemia | Blood and lymphatic system disorders | DB: Denosumab | 208 | 850 | |
| other | Anaemia | Blood and lymphatic system disorders | OL: Zoledronic Acid / Denosumab | 51 | 418 | |
| other | Anaemia | Blood and lymphatic system disorders | OL: Denosumab / Denosumab | 62 | 426 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | DB: Zoledronic Acid | 82 | 852 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | DB: Denosumab | 89 | 850 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | OL: Zoledronic Acid / Denosumab | 9 | 418 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | OL: Denosumab / Denosumab | 2 | 426 | |
| other | Neutropenia | Blood and lymphatic system disorders | DB: Zoledronic Acid | 166 | 852 | |
| other | Neutropenia | Blood and lymphatic system disorders | DB: Denosumab | 173 | 850 |
1 to 10 of 2,992Source ClinicalTrials.gov
See all 2,992 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DB: Zoledronic Acid | ||
| Total, all-cause mortality | DB: Denosumab | ||
| Total, all-cause mortality | OL: Zoledronic Acid / Denosumab | ||
| Total, all-cause mortality | OL: Denosumab / Denosumab | ||
| Total, other adverse events | DB: Zoledronic Acid | 778 | 852 |
| Total, other adverse events | DB: Denosumab | 757 | 850 |
| Total, other adverse events | OL: Zoledronic Acid / Denosumab | 313 | 418 |
| Total, other adverse events | OL: Denosumab / Denosumab | 312 | 426 |
| Total, serious adverse events | DB: Zoledronic Acid | 447 | 852 |
| Total, serious adverse events | DB: Denosumab | 434 | 850 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01345019
GET https://conductscience.org/api/trials/v1/NCT01345019/events?page=2