Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01345019
Registration number
NCT01345019
Ethics application status
Date submitted
28/04/2011
Date registered
29/04/2011
Titles & IDs
Public title
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
Query!
Scientific title
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
Query!
Secondary ID [1]
0
0
2010-020454-34
Query!
Secondary ID [2]
0
0
20090482
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cancer
0
0
Query!
Hematologic Malignancies
0
0
Query!
Multiple Myeloma
0
0
Query!
Oncology
0
0
Query!
Bone Metastases
0
0
Query!
Multiple Myeloma Bone Lesions
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Denosumab
Treatment: Drugs - Zoledronic acid
Treatment: Drugs - Placebo to Denosumab
Treatment: Drugs - Placebo to zoledronic acid
Treatment: Drugs - Denosumab (for the open-label treatment phase)
Active comparator: Zoledronic acid - Zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaniously (SC) once every 4 weeks (Q4W) in the double-blind treatment period (Since denosumab was determined to have a positive benefit:risk profile in the primary analysis of the study, per protocol, participants who were still undergoing Q4W scheduled assessments were offered open-label denosumab 120 mg SC Q4W for up to 2 years)
Experimental: Denosumab - Denosumab 120 mg subcutaniously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment period (Since denosumab was determined to have a positive benefit:risk profile in the primary analysis of the study, per protocol, participants who were still undergoing Q4W scheduled assessments were offered open-label denosumab 120 mg SC Q4W for up to 2 years)
Treatment: Drugs: Denosumab
Administered by subcutaneous injection once every 4 weeks.
Treatment: Drugs: Zoledronic acid
Administered by intravenous infusion over 15 minutes once every 4 weeks
Treatment: Drugs: Placebo to Denosumab
Administered by subcutaneous injection once every 4 weeks.
Treatment: Drugs: Placebo to zoledronic acid
Administered by intravenous infusion over 15 minutes once every 4 weeks
Treatment: Drugs: Denosumab (for the open-label treatment phase)
Administered by subcutaneous injection once every 4 weeks.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Time to First On-study Skeletal Related Event
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
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.
Query!
Primary outcome [2]
0
0
Percentage of Participants With an On-study Skeletal Related Event
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
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.
Query!
Primary outcome [3]
0
0
Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
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.
Query!
Secondary outcome [1]
0
0
Time to First On-study Skeletal Related Event - Superiority Analysis
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
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.
Query!
Secondary outcome [2]
0
0
Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
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.
Query!
Secondary outcome [3]
0
0
Time to First and Subsequent On-Study Skeletal Related Event - Number of Events
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
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.
Query!
Secondary outcome [4]
0
0
Overall Survival
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
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.
Query!
Secondary outcome [5]
0
0
Percentage of Participants Who Died
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
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.
Query!
Eligibility
Key inclusion criteria
* Documented evidence of multiple myeloma (per local assessment):
* Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma, and
* Monoclonal protein present in the serum and/or urine
* Radiographic (X-ray, or computer tomography [CT]) evidence of at least 1 lytic bone lesion (or at least 1 focal lesion per magnetic resonance imaging [MRI])
* Plan to receive or is receiving primary frontline anti-myeloma therapies
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Age = 18 years
* Adequate organ function, as defined by the following criteria (per central or local laboratory values):
* Serum aspartate aminotransferase (AST) = 2.0 x upper limit of normal (ULN)
* Serum alanine aminotransferase = (ALT) 2.0 x ULN
* Serum total bilirubin = 2.0 x ULN
* Creatinine clearance = 30 mL/min
* Serum calcium or albumin-adjusted serum calcium 2.0 mmol/L (8.0 mg/dL) and 2.9 mmol/L (11.5 mg/dL)
* Written informed consent before any study-specific procedure is performed
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Nonsecretory multiple myeloma based upon standard M-component criteria (ie, measurable serum/urine M-component) unless the baseline serum free light chain level is elevated
* POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
* Plasma cell leukemia
* More than 30 days of previous treatment (before screening) with anti-myeloma therapy (does not include radiotherapy or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 60 mg/day for 4 days]).
* Planned radiation therapy or surgery to the bone (does not include procedures performed before randomization)
* Prior administration of denosumab
* Use of oral bisphosphonates with a cumulative exposure of more than 1 year
* More than 1 previous dose of IV bisphosphonate administration
* Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
* Active dental or jaw condition which requires oral surgery, including tooth extraction
* Non-healed dental/oral surgery, including tooth extraction
* Planned invasive dental procedures
* Evidence of any of the following conditions per subject self-report or medical chart review:
* Any prior invasive malignancy within 5 years before randomization
* Any non-invasive malignancy not treated with curative intent or with knownactive disease within 5 years before randomization
* Major surgery or significant traumatic injury occurring within 4 weeks before randomization
* Active infection with Hepatitis B virus or Hepatitis C virus
* Known infection with human immunodeficiency virus (HIV)
* Active infection requiring IV anti-infective therapy
* Subject is pregnant or breast feeding, or planning to become pregnant within 5 months after end of treatment
* Female subject of child bearing potential is not willing to use highly effective contraception during treatment and for 5 months after the end of treatment (see section 6.3)
* Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D)
* Subject is receiving or is less than 30 days since ending other experimental device or drug (no marketing authorization for any indication)
* Subject will not be available for follow-up assessment
* Any major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/05/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
29/03/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1718
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Query!
Recruitment hospital [1]
0
0
Research Site - Liverpool
Query!
Recruitment hospital [2]
0
0
Research Site - Tweed Heads
Query!
Recruitment hospital [3]
0
0
Research Site - Douglas
Query!
Recruitment hospital [4]
0
0
Research Site - South Brisbane
Query!
Recruitment hospital [5]
0
0
Research Site - Hobart
Query!
Recruitment hospital [6]
0
0
Research Site - Clayton
Query!
Recruitment hospital [7]
0
0
Research Site - Epping
Query!
Recruitment hospital [8]
0
0
Research Site - Malvern
Query!
Recruitment hospital [9]
0
0
Research Site - Parkville
Query!
Recruitment hospital [10]
0
0
Research Site - Prahran
Query!
Recruitment postcode(s) [1]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [2]
0
0
2485 - Tweed Heads
Query!
Recruitment postcode(s) [3]
0
0
4814 - Douglas
Query!
Recruitment postcode(s) [4]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [5]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [6]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [7]
0
0
3076 - Epping
Query!
Recruitment postcode(s) [8]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [9]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [10]
0
0
3181 - Prahran
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Iowa
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kentucky
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Louisiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maine
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Michigan
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Mississippi
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Missouri
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Montana
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Nebraska
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Nevada
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
New Jersey
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New York
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
North Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
North Dakota
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Oklahoma
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Pennsylvania
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
South Carolina
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
South Dakota
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Tennessee
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Texas
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Utah
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Virginia
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Washington
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
West Virginia
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Wisconsin
Query!
Country [37]
0
0
Austria
Query!
State/province [37]
0
0
Graz
Query!
Country [38]
0
0
Austria
Query!
State/province [38]
0
0
Innsbruck
Query!
Country [39]
0
0
Austria
Query!
State/province [39]
0
0
Krems an der Donau
Query!
Country [40]
0
0
Austria
Query!
State/province [40]
0
0
Salzburg
Query!
Country [41]
0
0
Austria
Query!
State/province [41]
0
0
Wels
Query!
Country [42]
0
0
Austria
Query!
State/province [42]
0
0
Wien
Query!
Country [43]
0
0
Bulgaria
Query!
State/province [43]
0
0
Pleven
Query!
Country [44]
0
0
Bulgaria
Query!
State/province [44]
0
0
Plovdiv
Query!
Country [45]
0
0
Bulgaria
Query!
State/province [45]
0
0
Sofia
Query!
Country [46]
0
0
Bulgaria
Query!
State/province [46]
0
0
Varna
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
British Columbia
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Manitoba
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
New Brunswick
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Newfoundland and Labrador
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Ontario
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
Quebec
Query!
Country [53]
0
0
Czechia
Query!
State/province [53]
0
0
Brno
Query!
Country [54]
0
0
Czechia
Query!
State/province [54]
0
0
Ostrava-Poruba
Query!
Country [55]
0
0
Czechia
Query!
State/province [55]
0
0
Plzen
Query!
Country [56]
0
0
Czechia
Query!
State/province [56]
0
0
Praha 10
Query!
Country [57]
0
0
Czechia
Query!
State/province [57]
0
0
Praha 2
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Amiens Cedex 1
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Avignon Cedex 9
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Creteil
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Le Kremlin Bicetre
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Le Mans Cedex 9
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Le Mans
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Lille
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Lyon Cédex 3
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Marseille cedex 5
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Marseille Cedex 9
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Nantes Cedex 1
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Nice Cedex 3
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Paris Cedex 12
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Paris Cedex 14
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Paris
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Pessac Cedex
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Pierre-Benite cedex
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Pontoise Cedex
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Reims Cedex
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Rouen cedex
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Saint Quentin
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Strasbourg
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Villefranche Sur Saone Cedex
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Bonn
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Chemnitz
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Essen
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Hamburg
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Kassel
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Köln
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Leipzig
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Münster
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Regensburg
Query!
Country [90]
0
0
Greece
Query!
State/province [90]
0
0
Athens
Query!
Country [91]
0
0
Greece
Query!
State/province [91]
0
0
Heraklion
Query!
Country [92]
0
0
Greece
Query!
State/province [92]
0
0
Patra
Query!
Country [93]
0
0
Greece
Query!
State/province [93]
0
0
Piraeus
Query!
Country [94]
0
0
Greece
Query!
State/province [94]
0
0
Thessaloniki
Query!
Country [95]
0
0
Hong Kong
Query!
State/province [95]
0
0
Hong Kong
Query!
Country [96]
0
0
Hong Kong
Query!
State/province [96]
0
0
New Territories
Query!
Country [97]
0
0
Hungary
Query!
State/province [97]
0
0
Budapest
Query!
Country [98]
0
0
Hungary
Query!
State/province [98]
0
0
Debrecen
Query!
Country [99]
0
0
Hungary
Query!
State/province [99]
0
0
Gyor
Query!
Country [100]
0
0
Hungary
Query!
State/province [100]
0
0
Gyula
Query!
Country [101]
0
0
Hungary
Query!
State/province [101]
0
0
Kaposvar
Query!
Country [102]
0
0
Hungary
Query!
State/province [102]
0
0
Szeged
Query!
Country [103]
0
0
Ireland
Query!
State/province [103]
0
0
Dublin
Query!
Country [104]
0
0
Ireland
Query!
State/province [104]
0
0
Limerick
Query!
Country [105]
0
0
Ireland
Query!
State/province [105]
0
0
Tullamore
Query!
Country [106]
0
0
Italy
Query!
State/province [106]
0
0
Ancona
Query!
Country [107]
0
0
Italy
Query!
State/province [107]
0
0
Bari
Query!
Country [108]
0
0
Italy
Query!
State/province [108]
0
0
Brescia
Query!
Country [109]
0
0
Italy
Query!
State/province [109]
0
0
Busto Arsizio
Query!
Country [110]
0
0
Italy
Query!
State/province [110]
0
0
Catania
Query!
Country [111]
0
0
Italy
Query!
State/province [111]
0
0
Firenze
Query!
Country [112]
0
0
Italy
Query!
State/province [112]
0
0
Genova
Query!
Country [113]
0
0
Italy
Query!
State/province [113]
0
0
Messina
Query!
Country [114]
0
0
Italy
Query!
State/province [114]
0
0
Milano
Query!
Country [115]
0
0
Italy
Query!
State/province [115]
0
0
Napoli
Query!
Country [116]
0
0
Italy
Query!
State/province [116]
0
0
Novara
Query!
Country [117]
0
0
Italy
Query!
State/province [117]
0
0
Palermo
Query!
Country [118]
0
0
Italy
Query!
State/province [118]
0
0
Pescara
Query!
Country [119]
0
0
Italy
Query!
State/province [119]
0
0
Pisa
Query!
Country [120]
0
0
Italy
Query!
State/province [120]
0
0
Roma
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
Rozzano MI
Query!
Country [122]
0
0
Italy
Query!
State/province [122]
0
0
Torino
Query!
Country [123]
0
0
Italy
Query!
State/province [123]
0
0
Udine
Query!
Country [124]
0
0
Italy
Query!
State/province [124]
0
0
Vimercate MB
Query!
Country [125]
0
0
Japan
Query!
State/province [125]
0
0
Aichi
Query!
Country [126]
0
0
Japan
Query!
State/province [126]
0
0
Akita
Query!
Country [127]
0
0
Japan
Query!
State/province [127]
0
0
Chiba
Query!
Country [128]
0
0
Japan
Query!
State/province [128]
0
0
Fukuoka
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Gifu
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Gunma
Query!
Country [131]
0
0
Japan
Query!
State/province [131]
0
0
Hiroshima
Query!
Country [132]
0
0
Japan
Query!
State/province [132]
0
0
Hyogo
Query!
Country [133]
0
0
Japan
Query!
State/province [133]
0
0
Kumamoto
Query!
Country [134]
0
0
Japan
Query!
State/province [134]
0
0
Kyoto
Query!
Country [135]
0
0
Japan
Query!
State/province [135]
0
0
Okayama
Query!
Country [136]
0
0
Japan
Query!
State/province [136]
0
0
Saitama
Query!
Country [137]
0
0
Japan
Query!
State/province [137]
0
0
Tokushima
Query!
Country [138]
0
0
Japan
Query!
State/province [138]
0
0
Tokyo
Query!
Country [139]
0
0
Japan
Query!
State/province [139]
0
0
Toyama
Query!
Country [140]
0
0
Korea, Republic of
Query!
State/province [140]
0
0
Anyang
Query!
Country [141]
0
0
Korea, Republic of
Query!
State/province [141]
0
0
Busan
Query!
Country [142]
0
0
Korea, Republic of
Query!
State/province [142]
0
0
Daegu
Query!
Country [143]
0
0
Korea, Republic of
Query!
State/province [143]
0
0
Daejeon
Query!
Country [144]
0
0
Korea, Republic of
Query!
State/province [144]
0
0
Gwangju
Query!
Country [145]
0
0
Korea, Republic of
Query!
State/province [145]
0
0
Incheon
Query!
Country [146]
0
0
Korea, Republic of
Query!
State/province [146]
0
0
Seoul
Query!
Country [147]
0
0
Lithuania
Query!
State/province [147]
0
0
Kaunas
Query!
Country [148]
0
0
Lithuania
Query!
State/province [148]
0
0
Vilnius
Query!
Country [149]
0
0
Malaysia
Query!
State/province [149]
0
0
Perak
Query!
Country [150]
0
0
Malaysia
Query!
State/province [150]
0
0
Pinang
Query!
Country [151]
0
0
Malaysia
Query!
State/province [151]
0
0
Sarawak
Query!
Country [152]
0
0
Malaysia
Query!
State/province [152]
0
0
Ampang
Query!
Country [153]
0
0
New Zealand
Query!
State/province [153]
0
0
Christchurch
Query!
Country [154]
0
0
New Zealand
Query!
State/province [154]
0
0
Grafton, Auckland
Query!
Country [155]
0
0
Poland
Query!
State/province [155]
0
0
Legnica
Query!
Country [156]
0
0
Poland
Query!
State/province [156]
0
0
Lublin
Query!
Country [157]
0
0
Poland
Query!
State/province [157]
0
0
Slupsk
Query!
Country [158]
0
0
Poland
Query!
State/province [158]
0
0
Torun
Query!
Country [159]
0
0
Poland
Query!
State/province [159]
0
0
Warszawa
Query!
Country [160]
0
0
Poland
Query!
State/province [160]
0
0
Wroclaw
Query!
Country [161]
0
0
Portugal
Query!
State/province [161]
0
0
Braga
Query!
Country [162]
0
0
Portugal
Query!
State/province [162]
0
0
Coimbra
Query!
Country [163]
0
0
Portugal
Query!
State/province [163]
0
0
Lisboa
Query!
Country [164]
0
0
Portugal
Query!
State/province [164]
0
0
Matosinhos
Query!
Country [165]
0
0
Portugal
Query!
State/province [165]
0
0
Porto
Query!
Country [166]
0
0
Russian Federation
Query!
State/province [166]
0
0
Dzerzhinsk
Query!
Country [167]
0
0
Russian Federation
Query!
State/province [167]
0
0
Ekaterinburg
Query!
Country [168]
0
0
Russian Federation
Query!
State/province [168]
0
0
Moscow
Query!
Country [169]
0
0
Russian Federation
Query!
State/province [169]
0
0
Nizhny Novgorod
Query!
Country [170]
0
0
Russian Federation
Query!
State/province [170]
0
0
Novosibirsk
Query!
Country [171]
0
0
Russian Federation
Query!
State/province [171]
0
0
Penza
Query!
Country [172]
0
0
Russian Federation
Query!
State/province [172]
0
0
Petrozavodsk
Query!
Country [173]
0
0
Russian Federation
Query!
State/province [173]
0
0
Saint Petersburg
Query!
Country [174]
0
0
Russian Federation
Query!
State/province [174]
0
0
Saint-Petersburg
Query!
Country [175]
0
0
Russian Federation
Query!
State/province [175]
0
0
Samara
Query!
Country [176]
0
0
Russian Federation
Query!
State/province [176]
0
0
Saratov
Query!
Country [177]
0
0
Russian Federation
Query!
State/province [177]
0
0
St. Petersburg
Query!
Country [178]
0
0
Russian Federation
Query!
State/province [178]
0
0
Volgograd
Query!
Country [179]
0
0
Singapore
Query!
State/province [179]
0
0
Singapore
Query!
Country [180]
0
0
Slovakia
Query!
State/province [180]
0
0
Bratislava
Query!
Country [181]
0
0
Slovakia
Query!
State/province [181]
0
0
Nitra
Query!
Country [182]
0
0
Slovakia
Query!
State/province [182]
0
0
Nove Zamky
Query!
Country [183]
0
0
Spain
Query!
State/province [183]
0
0
Andalucía
Query!
Country [184]
0
0
Spain
Query!
State/province [184]
0
0
Baleares
Query!
Country [185]
0
0
Spain
Query!
State/province [185]
0
0
Castilla León
Query!
Country [186]
0
0
Spain
Query!
State/province [186]
0
0
Cataluña
Query!
Country [187]
0
0
Spain
Query!
State/province [187]
0
0
Comunidad Valenciana
Query!
Country [188]
0
0
Spain
Query!
State/province [188]
0
0
Galicia
Query!
Country [189]
0
0
Spain
Query!
State/province [189]
0
0
País Vasco
Query!
Country [190]
0
0
Spain
Query!
State/province [190]
0
0
Madrid
Query!
Country [191]
0
0
Switzerland
Query!
State/province [191]
0
0
Chur
Query!
Country [192]
0
0
Switzerland
Query!
State/province [192]
0
0
Zurich
Query!
Country [193]
0
0
Taiwan
Query!
State/province [193]
0
0
Changhua
Query!
Country [194]
0
0
Taiwan
Query!
State/province [194]
0
0
Kaohsiung
Query!
Country [195]
0
0
Taiwan
Query!
State/province [195]
0
0
Taichung
Query!
Country [196]
0
0
Taiwan
Query!
State/province [196]
0
0
Tainan
Query!
Country [197]
0
0
Taiwan
Query!
State/province [197]
0
0
Taipei
Query!
Country [198]
0
0
Taiwan
Query!
State/province [198]
0
0
Taoyuan
Query!
Country [199]
0
0
Turkey
Query!
State/province [199]
0
0
Adana
Query!
Country [200]
0
0
Turkey
Query!
State/province [200]
0
0
Ankara
Query!
Country [201]
0
0
Turkey
Query!
State/province [201]
0
0
Istanbul
Query!
Country [202]
0
0
Turkey
Query!
State/province [202]
0
0
Izmir
Query!
Country [203]
0
0
Ukraine
Query!
State/province [203]
0
0
Cherkasy
Query!
Country [204]
0
0
Ukraine
Query!
State/province [204]
0
0
Dnipropetrovsk
Query!
Country [205]
0
0
Ukraine
Query!
State/province [205]
0
0
Ivano-Frankivsk
Query!
Country [206]
0
0
Ukraine
Query!
State/province [206]
0
0
Khmelnitskiy
Query!
Country [207]
0
0
Ukraine
Query!
State/province [207]
0
0
Kyiv
Query!
Country [208]
0
0
Ukraine
Query!
State/province [208]
0
0
Lviv
Query!
Country [209]
0
0
Ukraine
Query!
State/province [209]
0
0
Poltava
Query!
Country [210]
0
0
United Kingdom
Query!
State/province [210]
0
0
Harrow
Query!
Country [211]
0
0
United Kingdom
Query!
State/province [211]
0
0
Inverness
Query!
Country [212]
0
0
United Kingdom
Query!
State/province [212]
0
0
Leeds
Query!
Country [213]
0
0
United Kingdom
Query!
State/province [213]
0
0
London
Query!
Country [214]
0
0
United Kingdom
Query!
State/province [214]
0
0
Oxford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Amgen
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Daiichi Sankyo
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01345019
Query!
Trial related presentations / publications
Raje N, Roodman GD, Willenbacher W, Shimizu K, Garcia-Sanz R, Terpos E, Kennedy L, Sabatelli L, Intorcia M, Hechmati G. A cost-effectiveness analysis of denosumab for the prevention of skeletal-related events in patients with multiple myeloma in the United States of America. J Med Econ. 2018 May;21(5):525-536. doi: 10.1080/13696998.2018.1445634. Epub 2018 Mar 5. Raje N, Terpos E, Willenbacher W, Shimizu K, Garcia-Sanz R, Durie B, Legiec W, Krejci M, Laribi K, Zhu L, Cheng P, Warner D, Roodman GD. Denosumab versus zoledronic acid in bone disease treatment of newly diagnosed multiple myeloma: an international, double-blind, double-dummy, randomised, controlled, phase 3 study. Lancet Oncol. 2018 Mar;19(3):370-381. doi: 10.1016/S1470-2045(18)30072-X. Epub 2018 Feb 9. Huang SY, Yoon SS, Shimizu K, Chng WJ, Chang CS, Wong RS, Gao S, Wang Y, Gordon SW, Glennane A, Min CK. Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study-Asian Subgroup Analysis. Adv Ther. 2020 Jul;37(7):3404-3416. doi: 10.1007/s12325-020-01395-x. Epub 2020 Jun 10. Terpos E, Raje N, Croucher P, Garcia-Sanz R, Leleu X, Pasteiner W, Wang Y, Glennane A, Canon J, Pawlyn C. Denosumab compared with zoledronic acid on PFS in multiple myeloma: exploratory results of an international phase 3 study. Blood Adv. 2021 Feb 9;5(3):725-736. doi: 10.1182/bloodadvances.2020002378.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
MD
Query!
Address
0
0
Amgen
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Query!
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01345019