UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy
Title of the study (Brief 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 (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	Tsutomu Sato
Organization	Sapporo Medical University Hospital
Division name	Fourth Department of Internal Medicine
Address	S-1, -16, Chuo-ku, Sapporo
TEL	011-611-2111
Email	tsutomus@sapmed.ac.jp

Public contact
Name of contact person	Tsutomu Sato
Organization	Sapporo Medical University Hospital
Division name	Fourth Department of Internal Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014450