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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012362
Receipt No. R000014450
Scientific Title A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy
Date of disclosure of the study information 2013/11/21
Last modified on 2017/05/24

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Basic information
Public title A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy
Acronym A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy (SMUIM4-NHL01)
Scientific Title A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy
Scientific Title:Acronym A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy (SMUIM4-NHL01)
Region
Japan

Condition
Condition Malignant Lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluating the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in bone mineral density
Change in bone metabolism markers
Key secondary outcomes Incidence rate of pathological bone fracture
Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Malignant lymphoma patients with osteoporosis will be administered with 60 mg of denosumab once within one week before the start of prednisolone-containing chemotherapy and with calcium and Vitamin D daily.
Interventions/Control_2 Malignant lymphoma patients without osteoporosis will not be administered with denosumab.
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria PS 0-2
Aged &#8805;20 and &#8804;90
Patients whose prognosis would be expected more than 3 months
Written informed consent
Key exclusion criteria Uncontrolled hepatic disease, renal disease, heart disease, lung disease, diabetes mellitus, hypertention and infectious disease
Active concomitant malignancy
Severe psychiatric disorders
Women who are pregnant or in lactation
Hypersensitivity to the denosumab
Dental therapy during this trial
Current hypocalcemia
Patient judged inappropriate for this study by the physicians
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Sato
Organization Sapporo Medical University Hospital
Division name Fourth Department of Internal Medicine
Zip code
Address S-1, -16, Chuo-ku, Sapporo
TEL 011-611-2111
Email tsutomus@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Sato
Organization Sapporo Medical University Hospital
Division name Fourth Department of Internal Medicine
Zip code
Address S-1, -16, Chuo-ku, Sapporo
TEL 011-611-2111
Homepage URL
Email tsutomus@sapmed.ac.jp

Sponsor
Institute Department of Medical Oncology and Hematology, Sapporo Medical University, School of Medicine
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2013 Year 11 Month 21 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 Completed
Date of protocol fixation
2013 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 20 Day
Last modified on
2017 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014450

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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