UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017819 |
|---|---|
| Receipt number | 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 10:35:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
movement@mebix.co.jp
Sponsor or person
Institute
MOVEMENT Study Protocol Review Committee (executive committee)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020644
