UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the efficacy and safety of romosozumab alone and romosozumab + denosumab combination for patients with osteoporosis treated with 2-year denosumab
Acronym	Evaluation of the efficacy and safety of romosozumab alone and romosozumab + denosumab combination for patients with osteoporosis treated with 2-year denosumab
Scientific Title	Evaluation of the efficacy and safety of romosozumab alone and romosozumab + denosumab combination for patients with osteoporosis treated with 2-year denosumab
Scientific Title:Acronym	Evaluation of the efficacy and safety of romosozumab alone and romosozumab + denosumab combination for patients with osteoporosis treated with 2-year denosumab
Region	Japan

Condition
Condition	osteoporosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to examine the efficacy and safety of the two treatments of romosozumab alone and romosozumab plus denosumab after 2 years of treatment with osteoporosis for osteoporosis patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Bone mineral density at 12 months after treatment
Key secondary outcomes	Occurrence of hypocalcemia Occurrence of other adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	romosozumab plus active vitamin D group
Interventions/Control_2	romosozumab + denosumab plus active vitamin D group
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1:All osteoporosis patients over 20 years old or older (but does not correspond to the following exclusion criteria)3 2: Patients who have already received Denosumab (60 mg once every 6 months) for 2 years before the start of the study and have a YAM value of 70% or more or a bone density value of less than -2.5 SD 3:Patients who agree with this study
Key exclusion criteria	1:Patients who have taken romosozumab or denosumab before 2:Patients who are allergic to romosozumab or denosumab or eldecalcitol 3:Hypocalcemia 4:Pregnant or breast-feeding patients 5:Patients with severe renal function (eGFR 30 ml / min / 1.73 m2) or patients undergoing dialysis 6:Patients at risk of hypercalcemia (patients with renal dysfunction, patients with malignancy, patients with primary hyperparathyroidism) 7:Patients with severe liver dysfunction 8:Patients with urolithiasis and patients with a history of their history
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yukio Middle name Last name Nakamura
Organization	Shinshu University School of Medicine
Division name	Dept. of Orthopaedic Surgery
Zip code	390-8621
Address	Asahi 3-1-1, Matsumoto 3908621, Japan
TEL	0263372659
Email	yxn14@aol.jp

Public contact
Name of contact person	1st name Yukio Middle name Last name Nakamura
Organization	Shinshu University School of Medicine
Division name	Dept. of Orthopaedic Surgery
Zip code	390-8621
Address	Asahi 3-1-1, Matsumoto 3908621, Japan
TEL	0263372659
Homepage URL
Email	yxn14@aol.jp

Sponsor
Institute	Shinshu University School of Medicine Dept. of Orthopaedic Surgery
Institute
Department

Funding Source
Organization	Shinshu University School of Medicine Dept. of Orthopaedic Surgery
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	Shinshu University School of Medicine Dept. of Orthopaedic Surgery
Address	Asahi 3-1-1, Matsumoto 3908621, Japan
Tel	0263372659
Email	yxn14@aol.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	2019 Year 06 Month 20 Day

Related information
URL releasing protocol
Publication of results	Partially published

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 06 Month 06 Day
Date of IRB	2019 Year 06 Month 10 Day
Anticipated trial start date	2019 Year 06 Month 20 Day
Last follow-up date	2021 Year 06 Month 03 Day
Date of closure to data entry	2024 Year 06 Month 03 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 20 Day
Last modified on	2019 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042296