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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038881
Receipt No. 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 2019/12/13

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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
Email 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
Email tsutomus@med.u-toyama.ac.jp

Sponsor
Institute Toyama University Hospital
Department of Hematology
Institute
Department

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
Email 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 Preinitiation
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
2019 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044265

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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