UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012226
Receipt number R000014293
Scientific Title Efficacy evaluation on switching to 50mg of minodronic acid hydrate in patients with osteoporosis
Date of disclosure of the study information 2013/11/06
Last modified on 2018/03/13 15:41:42

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Basic information

Public title

Efficacy evaluation on switching to 50mg of minodronic acid hydrate in patients with osteoporosis

Acronym

A study for effects on switching to minodronic acid hydrate in patients with osteoporosis

Scientific Title

Efficacy evaluation on switching to 50mg of minodronic acid hydrate in patients with osteoporosis

Scientific Title:Acronym

A study for effects on switching to minodronic acid hydrate in patients with osteoporosis

Region

Japan


Condition

Condition

osteoporosis

Classification by specialty

Obstetrics and Gynecology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to determine switching efficacy and safety of 1-year treatment of monthly minodronic acid hydrate (MIN-M) in osteoporotic patients treated with other bisphosphonate.s.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in bone mineral density

Key secondary outcomes

-Changes in bone metabolic markers
-Changes in pain symptoms
-Changes in abdominal symptoms
-Changes in patients will for medication


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients included are to be given 50 mg of minodronic acid hydrate once every 4 weeks

Interventions/Control_2


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

-Patients on medication with bisphosphonates (other than monodronic acid) diagnosed with primary osteoporosis
-Patients who consent to their participation in the study and can answer questionnaires

Key exclusion criteria

Patients who have withdrawn their consent to participation in the study
-Patients who discontinued their medication with minodronic acid hydrate

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name koichiro morishita

Organization

Yokkaichi Social Insurance Hospital

Division name

Department of Orthopedic Surgery

Zip code


Address

10-8 Haduyama-cho, Yokkaichi-shi, Mie, Japan

TEL

059-331-2000

Email

seikeiteam@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name koichiro morishita

Organization

Yokkaichi Social Insurance Hospital

Division name

Department of Orthopedic Surgery

Zip code


Address

10-8 Haduyama-cho, Yokkaichi-shi, Mie, Japan

TEL

059-331-2000

Homepage URL


Email

seikeiteam@yahoo.co.jp


Sponsor or person

Institute

Yokkaichi Social Insurance Hospital

Institute

Department

Personal name



Funding Source

Organization

Astellas Pharma Inc.

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

2013 Year 11 Month 06 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

2013 Year 02 Month 28 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 11 Month 06 Day

Last modified on

2018 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014293


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name