UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of efficacy and safety of romosozumab administration group and ibandronate sodium hydrate administration group for osteoporosis patients after denosumab treatment
Acronym	Evaluation of efficacy and safety of romosozumab administration group and ibandronate sodium hydrate administration group for osteoporosis patients after denosumab treatment
Scientific Title	Evaluation of efficacy and safety of romosozumab administration group and ibandronate sodium hydrate administration group for osteoporosis patients after denosumab treatment
Scientific Title:Acronym	Evaluation of efficacy and safety of romosozumab administration group and ibandronate sodium hydrate administration group for osteoporosis patients after denosumab treatment
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 group and ibandronate sodium hydrate group in cases where bone density has increased after administration of denosumab for 2 or more years to 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 density at 12 months of treatment Younger average 80% achieved
Key secondary outcomes	Occurrence of hypocalcemia Occurrence of other adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	romosozumab group
Interventions/Control_2	ibandronate sodium hydrate 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 2. Patients who have already received Denosumab (60 mg once every 6 months) for 2 years or more before the start of the study, and have a bone density value of -2.0 SD or more 3.Patients who received written informed consent based on their own free will after receiving sufficient explanation for participation in this study
Key exclusion criteria	1. If you had previously been treated with romosozumab, ibandronate sodium hydrate 2. If you are allergic to romosozumab, ibandronate sodium hydrate 3. Those who have hypocalcemia 4. For pregnant women or women who are nursing 5.Patients with disorders that delay esophageal passage such as esophageal stricture or achalasia 6.Patients who can not keep standing or sitting for more than 60 minutes when taking 7. Those with severe renal dysfunction (eGFR 30 ml / min / less than 1.73 m2) or those receiving dialysis 8.Patients with upper digestive tract disorder such as dysphagia, esophagitis, gastritis, duodenitis, ulcer etc. 9. Other patients who the research director judged inappropriate as a subject
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	hinshu 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 07 Month 17 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	Open public recruiting
Date of protocol fixation	2019 Year 07 Month 01 Day
Date of IRB	2019 Year 07 Month 11 Day
Anticipated trial start date	2019 Year 07 Month 16 Day
Last follow-up date	2024 Year 07 Month 02 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 07 Month 17 Day
Last modified on	2019 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042631