UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008931 |
|---|---|
| Receipt number | R000010470 |
| Scientific Title | Efficacy of minodronic acid hydrate to osteoporotic patients |
| Date of disclosure of the study information | 2012/09/20 |
| Last modified on | 2012/09/15 21:45:44 |
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Basic information
Public title
Efficacy of minodronic acid hydrate
to osteoporotic patients
Acronym
Efficacy of minodronic acid hydrate
to osteoporotic patients
Scientific Title
Efficacy of minodronic acid hydrate
to osteoporotic patients
Scientific Title:Acronym
Efficacy of minodronic acid hydrate
to osteoporotic patients
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the safety and efficacy of minodronic acid hydrate in osteoporotic patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Changes of lumbar BMD form baseline
Key secondary outcomes
Changes of femoral neck BMD form baseline
Changes of the bone markers from baseline
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is 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
the effect of alfacalcidol in Japanese patients with primary osteoporosis
Interventions/Control_2
the effect of minodronic acid hydrate
in Japanese patients with primary osteoporosis
Interventions/Control_3
the effect of combination therapy in
Japanese patients with primary osteoporosis
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
primary osteoporosis
Key exclusion criteria
1. Secondary osteoporosis
2. Patients treated with other bisphosphonates within the previous 12 months
3. Patient with peptic ulcer and esophageal stenosis and achalasia
4. The patient who lacks in ability for judgment for dementia remarkably
5. The patient who cannot wake up the upper part of the body at the time of remedy more than 30 minutes
6. The patient with hypocalcemia
7. Inappropriate to participate in this study as judged by the physician in charge
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takami Miki |
Organization
Graduate School of Medicine, Osaka City University
Division name
Gerontology
Zip code
Address
1-4-3 Asahi-machi Osakashiabeno-ku, Osaka-hu
TEL
06-6645-3889
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Masaki |
Organization
Graduate School of Medicine, Osaka City University
Division name
Gerontology
Zip code
Address
1-4-3 Asahi-machi Osakashiabeno-ku, Osaka-hu
TEL
06-6645-3889
Homepage URL
Sponsor or person
Institute
Gerontology,Graduate School of Medicine, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪市立大学医学部附属病院 老年内科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 21 | 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
| 2012 | Year | 09 | Month | 15 | Day |
Last modified on
| 2012 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010470
