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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009959
Receipt No. R000011662
Scientific Title Retrospective study of Clinical utility(included pain evaluation) by monthly minodronic acid hydrate for Osteoporosis.
Date of disclosure of the study information 2013/02/05
Last modified on 2013/11/14

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Basic information
Public title Retrospective study of Clinical utility(included pain evaluation) by monthly minodronic acid hydrate for Osteoporosis.
Acronym Retrospective study of Clinical utility by monthly minodronic acid hydrate for Osteoporosis.
Scientific Title Retrospective study of Clinical utility(included pain evaluation) by monthly minodronic acid hydrate for Osteoporosis.
Scientific Title:Acronym Retrospective study of Clinical utility by monthly minodronic acid hydrate for Osteoporosis.
Region
Japan

Condition
Condition Osteoporosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Retrospective study for osteoporosis patient treated by monthly minodronic acid hydrate (MIN-M).
Investigate clinical utility of the pain, the bone turnover marker, and bone density.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Low back pain by VAS-Scale
Change of bone turnover markers
Change of bone mineral density
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.The patient who has been newly diagnosed as osteoporosis from Oct.2011 to July 2012, with carried MIN-M medical treatment.
2.The patients whose pain VAS score at the time of a MIN-M medication start was four or more.
Key exclusion criteria 1.The patient who offered refused.
2.Investigator judged to be unsuitable as an object of this study.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Yoshida
Organization Yoshida Orthopedics Clinic
Division name Orthopedic Surgery
Zip code
Address 49-54 Tateishi Matsumae-city Matsumae Hokaido JAPAN
TEL +81-139-42-5770
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yoshida
Organization Yoshida Orthopedics Clinic
Division name Orthopedic Surgery
Zip code
Address 49-54 Tateishi Matsumae-city Matsumae Hokaido JAPAN
TEL +81-139-42-5770
Homepage URL
Email

Sponsor
Institute Yoshida Orthopedics Clinic
Institute
Department

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 よしだ整形外科(北海道)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.medicalonline.jp/
Number of participants that the trial has enrolled
Results 56 persons who showed four or more VAS scores in 120 persons were examined.
About the pain VAS score, it compared before medication, the fall more significant than one week was shown, and it gradually decreased till 24 weeks.
The increase in bone mass density till 24 weeks too.
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 01 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study of Clinical utility(included pain evaluation)by monthly minodronic acid hydrate for Osteoporosis.
The following is investigated and analyzed.
Low back pain(VAS-Scale)
Change of bone turnover markers
Change of bone mineral density

Management information
Registered date
2013 Year 02 Month 05 Day
Last modified on
2013 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011662

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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