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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011407
Receipt No. R000013355
Scientific Title Comparative study of efficacy of minodronate, alendronate and risedronate in patients with osteoporosis
Date of disclosure of the study information 2013/08/07
Last modified on 2013/08/07

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Basic information
Public title Comparative study of efficacy of minodronate, alendronate and risedronate in patients with osteoporosis
Acronym Comparison of efficacy of bisphosphonates in patients with osteoporosis
Scientific Title Comparative study of efficacy of minodronate, alendronate and risedronate in patients with osteoporosis
Scientific Title:Acronym Comparison of efficacy of bisphosphonates in patients with osteoporosis
Region
Japan

Condition
Condition Osteoporosis
Classification by specialty
Medicine in general Endocrinology and Metabolism Obsterics and gynecology
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness of minodronate in osteoporotic patients, and to compare with those of traditional bisphosphonates
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in bone mineral density
Key secondary outcomes Changes in TRACP-5b and BAP
Changes in low back pain
Changes in IZUMO scale score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Minodronic acid
Interventions/Control_2 Alendronate
Interventions/Control_3 Risedronate
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Outpatients diagnosed with osteoporosis
Key exclusion criteria 1. Patients with esophageal stricture or achalasia
2. Patients unable to remain upright for 30 min after dosing
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Nishiike
Organization Kushiro-sanjikai Hospital
Division name Department of Orthopaedic Surgery
Zip code
Address 4-30 Nusamaicho Kushiro Hokkaido 085-0836 Japan
TEL 0154-41-1199
Email

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Nishiike
Organization Kushiro-sanjikai Hospital
Division name Department of Orthopaedic Surgery
Zip code
Address 4-30 Nusamaicho Kushiro Hokkaido 085-0836 Japan
TEL 0154-41-1199
Homepage URL
Email

Sponsor
Institute Kushiro-sanjikai Hospital
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

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 07 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 Open public recruiting
Date of protocol fixation
2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 08 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 08 Month 07 Day
Last modified on
2013 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013355

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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