UMIN-CTR Clinical Trial

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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