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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017819
Receipt No. R000020644
Scientific Title The effect of Monthly ibandronate iv injected on the low-responders to pre-existing oral BP treatment for the osteoporosis patients
Date of disclosure of the study information 2015/06/05
Last modified on 2019/03/05

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Basic information
Public title The effect of Monthly ibandronate iv injected on the low-responders to pre-existing oral BP treatment for the osteoporosis patients
Acronym MOVEMENT Study
Scientific Title The effect of Monthly ibandronate iv injected on the low-responders to pre-existing oral BP treatment for the osteoporosis patients
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Hagino
Organization Tottori University
Division name School of Health Science, Faculty of Medicine.
Zip code
Address 86 Nishi-cho, Yonago-shi, Tottori
TEL 0859-38-6342
Email hagino@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Kojima
Organization Mebix, Inc.
Division name Research promotion division
Zip code
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)

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
2015 Year 06 Month 05 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
2015 Year 05 Month 08 Day
Date of IRB
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

Other
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

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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