UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038881 |
|---|---|
| Receipt number | R000044265 |
| Scientific Title | The effects of denosumab compared with alendronate on glucocorticoid-induced osteoporosis in patients with malignant lymphoma |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2022/05/17 14:30:36 |
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Basic information
Public title
The effects of denosumab compared with alendronate on glucocorticoid-induced osteoporosis in patients with malignant lymphoma
Acronym
DENOSULY trial
Scientific Title
The effects of denosumab compared with alendronate on glucocorticoid-induced osteoporosis in patients with malignant lymphoma
Scientific Title:Acronym
DENOSULY trial
Region
| Japan |
Condition
Condition
glucocorticoid-induced osteoporosis in patients with malignant lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the effects of denosumab with alendronate on glucocorticoid-induced osteoporosis in patients with malignant lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change of bone mineral density of the lumbar spine at 12 months after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Denosumab group: subcutaneous denosumab 60mg every 6 months and oral calcitriol 0.25ug daily for 1 year since before the start of chemotherapy
Interventions/Control_2
Alendronate group: oral alendronate 35mg once a week and oral calcitriol 0.25ug daily for 1 year since before the start of chemotherapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with newly diagnosed malignant lymphoma
Patients older than 65 years
Patients who undergo chemotherapy with steroid such as R-CHOP and R-CHOP-like regimen
Patients who signed the informed consent form
Key exclusion criteria
Patients with a history of hypersensitivity to any component of denosumab
Patients with hypocalcemia
Patients who are pregnant and who may be pregnant
Patients with a condition that makes swallowing difficult such as stenosis and achalasia of esophagus
Patients unable to sit upright or stand more than thirty minutes
Patients with a history of hypersensitivity to bisphosphonates
Patients with hypercalcemia or hypervitaminosis D
Patients who are on osteoporotic treatment with denosumab or bisphosphonates
Patients thought to be inappropriate for this study by physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Sato |
Organization
Toyama University Hospital
Division name
Department of Hematology
Zip code
930-0194
Address
2630, Sugitani, Toyama
TEL
076-434-7301
tsutomus@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Sato |
Organization
Toyama University Hospital
Division name
Department of Hematology
Zip code
930-0194
Address
2630, Sugitani, Toyama
TEL
076-434-7301
Homepage URL
tsutomus@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama University Hospital
Department of Hematology
Institute
Department
Personal name
Funding Source
Organization
Toyama University Hospital
Department of Hematology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama University Hospital, Department of Hematology
Address
2630, Sugitani, Toyama
Tel
076-434-7301
tsutomus@med.u-toyama.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 13 | Day |
Last modified on
| 2022 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044265
