UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011087 |
|---|---|
| Receipt number | R000012981 |
| Scientific Title | Efficacy of monthly minodronate for the treatment of osteoporosis associated with rheumatoid arthritis after previous treatment with bisphosphonates |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2018/03/08 08:35:39 |
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Basic information
Public title
Efficacy of monthly minodronate for the treatment of osteoporosis associated with rheumatoid arthritis after previous treatment with bisphosphonates
Acronym
Efficacy of monthly minodronate for osteoporosis in RA
Scientific Title
Efficacy of monthly minodronate for the treatment of osteoporosis associated with rheumatoid arthritis after previous treatment with bisphosphonates
Scientific Title:Acronym
Efficacy of monthly minodronate for osteoporosis in RA
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Clinical immunology |
| Obstetrics and Gynecology | Orthopedics | Adult |
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
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Changes in bone mineral density
(2) Changes TRACP-5b, CTX, P1NP, BAP, uDPD, ucOC, MMP-3, CRP, 1,25(OH)2VtD, serumCa, and serumP
Key secondary outcomes
(1) MHAQ
(2) mini-JOQOL
(3) Patient Satisfaction Questionnaire
(4) Treatment adherence
(5) Side effects
(6) 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
Minodronic acid (50mg/month or 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. RA patients with osteoporosis taking BPs for at least three months
2. Patients with RA for at least six months
Key exclusion criteria
1. Patients who underwent rheumatoid arthritis surgery less than three months before entry
2. Patients experienced any fracture less than three months before surgery
3. Patients with active RA and inadequate response to treatment
4. Patients with peptic ulcers
5. Patients with esophageal stricture or achalasia
6. Patients unable to remain upright for 30 min after dosing
7. Patients with hypocalcaemia
8. Females with pregnancy and lactating
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenrin Shi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenrin Shi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
TEL
06-6879-3552
Homepage URL
Sponsor or person
Institute
Osaka University Graduate School of Medicine
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
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 | 07 | Month | 01 | 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
| 2012 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 11 | 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 | 07 | Month | 01 | Day |
Last modified on
| 2018 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012981
