UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of Monthly ibandronate iv injected on the low-responders to pre-existing oral BP treatment for the osteoporosis patients
Title of the study (Brief title)	MOVEMENT Study
Region	Japan

Condition
Condition	Osteoporosis
Classification by specialty	Endocrinology and Metabolism Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effects of ibandronate (IBN) on bone mineral density (lumbar spine) will be investigated. IBN will be intravenously administered to patients with osteoporosis in which the bone mineral density is not improved even though treatment with oral BP has been provided for at least one to less than three years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in bone mineral density (lumbar spine) from the baseline in the IBN group (at 12 months after start of treatment)
Key secondary outcomes	Change in bone mineral density (Femur) and bone turnover markers Responder of bone mineral density (lumbar spine) Comparison between IBN group and observation group

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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	IBN group: IBN will be intravenously administered once a month at a dose of 1 mg.
Interventions/Control_2	Another BPs
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Those who are diagnosed with primary osteoporosis in accordance with the diagnostic guidelines for primary osteoporosis established by the Japanese Society for Bone and Mineral Research (revised in 2012) and fulfill the following criteria will be eligible for the study: 1) Those who have been treated with oral BP for at least one to less than three years (Response to a questionnaire about medications states that treatment with oral BP has been provided and that the medication adherence rate for the past one year was more than 75%.) 2) Lumbar spine (L1-4 or L2-4) bone mineral density shows a decreasing trend 3) Aged 50 years or more when providing informed consent 4) Provided written informed consent at the time of participation in the study
Key exclusion criteria	1) Patients with secondary osteoporosis 2) Lumbar spine bone mineral density (L1-4 or L2-4) T-score<-4.0 L1-4: <0.453 g/cm2 for males and <0.541 g/cm2 for females L2-4: <0.500 g/cm2 for males and <0.534 g/cm2 for females 3) There are findings that may affect the measurement of bone mineral density using DXA. 4) There are at least two fractures in L1-4. 5) Any of the following drugs was administered within eight weeks before enrollment: SERM preparation, sex hormone preparation, adrenal corticosteroid preparation, insulin preparation 6) Any of the following drugs was administered within one year before enrollment: PTH preparation, anti-RANKL antibody preparation, anti-sclerostin antibody preparation, cathepsin K inhibitors, zoledronic acid hydrate, alendronate sodium hydrate, and intravenous fluid preparation 7) Has received intravenous IBN administration 8) Corrected serum Ca level at enrollment is less than 8.4 mg/dL 9) Women who are, are likely to be, or want to become pregnant 10) Those who have a severe heart disease, kidney disease, or liver disease 11) Those who are hypersensitive for BP preparations 12) Those who have active malignant tumor 13) Those who are ineligible for the study judged by the investigator
Target sample size	400

Research contact person
Name of lead principal investigator	Hiroshi Hagino
Organization	Tottori University
Division name	School of Health Science, Faculty of Medicine.
Address	86 Nishi-cho, Yonago-shi, Tottori
TEL	0859-38-6342
Email	hagino@med.tottori-u.ac.jp

Public contact
Name of contact person	Naoko Kojima
Organization	Mebix, Inc.
Division name	Research promotion division
Address	Toranomon 15moribiru, 2-8-10 Toranomon, Minato-ku, Tokyo, 105-0001, Japan
TEL	03-4362-4504
Homepage URL
Email	movement@mebix.co.jp

Sponsor
Institute	MOVEMENT Study Protocol Review Committee (executive committee)
Institute
Department

Funding Source
Organization	Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	2015 Year 06 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 08 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
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	2015 Year 06 Month 05 Day
Last modified on	2019 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020644