UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011896 |
|---|---|
| Receipt number | R000013894 |
| Scientific Title | Efficacy and safety of minodronate in the treatment of glucocorticoid-induced osteoporosis |
| Date of disclosure of the study information | 2013/09/27 |
| Last modified on | 2013/09/27 17:17:09 |
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Basic information
Public title
Efficacy and safety of minodronate in the treatment of glucocorticoid-induced osteoporosis
Acronym
Effect of minodronate in glucocorticoid-induced osteoporosis
Scientific Title
Efficacy and safety of minodronate in the treatment of glucocorticoid-induced osteoporosis
Scientific Title:Acronym
Effect of minodronate in glucocorticoid-induced osteoporosis
Region
| Japan |
Condition
Condition
lucocorticoid-induced osteoporosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Clinical immunology |
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of minodronate in the treatment of glucocorticoid-induced osteoporosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Changes in bone mineral density
Key secondary outcomes
(1) Changes in TRACP-5b, CTX, BAP, uNTX
(2) Incident fracture
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
Minodronate (1mg/day)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with rheumatic (connective tissue) diseases complicated with osteoporosis during the treatment with glucocorticoid
Key exclusion criteria
(1) Patients with peptic ulcers
(2) Patients with esophageal stricture or achalasia
(3) Patients unable to remain upright for 30 min after dosing
4) Patients with hypocalcaemia
(5) Patients who received any prior bisphosphonate less than six months before entry
(6) Females with pregnancy and lactating
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Kitamura |
Organization
epartment of Medicine, School of Medicine, Nihon University
Division name
Division of Hematology and Rheumatology,
Zip code
Address
30-1 Oyaguchi Kamimachi Itabashi-ku, Tokyo 173-8610, Japan
TEL
03-3972-8111
noboruk@med.nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noboru Kitamura |
Organization
Department of Medicine, School of Medicine, Nihon University
Division name
Division of Hematology and Rheumatology
Zip code
Address
30-1 Oyaguchi Kamimachi Itabashi-ku, Tokyo 173-8610, Japan
TEL
03-3972-8111
Homepage URL
noboruk@med.nihon-u.ac.jp
Sponsor or person
Institute
Department of Medicine, School of Medicine, Nihon University
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 27 | 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
| 2011 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 27 | Day |
Last modified on
| 2013 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013894
