UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022364
Receipt number R000025762
Scientific Title Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis
Date of disclosure of the study information 2016/05/20
Last modified on 2019/02/12 11:09:31

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Basic information

Public title

Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis

Acronym

Effectiveness of minodronate in osteoporotic patients with rheumatoid arthritis

Scientific Title

Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis

Scientific Title:Acronym

Effectiveness of minodronate in osteoporotic patients with rheumatoid arthritis

Region

Japan


Condition

Condition

Osteoprotic patients with rheumatoid arthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To build preliminary data of effectiveness and safety for 2 different treatments; 1) minodoronate alone or 2) minodronate plus active vitamin D in osteoporotic patients with rheumatoid arthritis

Basic objectives2

Others

Basic objectives -Others

N/A

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Value changes of bone mineral density (lumber as well as bilateral proximal hip) before treatment and at 24 months after treatment

Key secondary outcomes

Frequencies of adverse effects (at 6, 12, and 24 months after treatment)
Value chanes of the following at 6, 12, and 24 months after treatment
1. Bone mineral density (lumber as well as bilateral proximal hip) values
2. Values of bone turnover markers
3. Values of serum vitamin D
4. Values of serum PTH


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is 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

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The selection criteria is based on which treatment each patient wants to take

Interventions/Control_2

Minodronate group: oral intake 50mg per month

Interventions/Control_3

Minodronate plus active vitamin D group: oral intake 50mg minodronate per month and eldecalcitol 0.75ug per day after breakfast

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Rheumatoid arthritis compliactated with steoporosis, aged over 20.
2. The patients who desire to take the above treatment
3. The patients who agree to perform this study after sufficient informed consent

Key exclusion criteria

1. The patients who are allergic to minodronate or eldecalcitol
2. The patients with hypercalcemia before treatment
3. The patients whom we judge as inappropriate

Target sample size

140


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukio Nakamura

Organization

Shinshu University School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code


Address

Asahi3-1-1, Matsumoto 3908621, Japan

TEL

0263372659

Email

yxn14@aol.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukio Nakamura

Organization

Shinshu University School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code


Address

Asahi3-1-1, Matsumoto 3908621, Japan

TEL

0263372659

Homepage URL

https://shinshu.bvits.com/rinri/Apply/show.aspx?TYPE=0&ID=2426

Email

yxn14@aol.jp


Sponsor or person

Institute

Department of Orthopaedic Surgery
Shinshu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ono Pharmaceutical Company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

2016 Year 05 Month 20 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

Completed

Date of protocol fixation

2016 Year 05 Month 09 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 10 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 05 Month 19 Day

Last modified on

2019 Year 02 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025762


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name