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

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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 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


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

Value
https://center6.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