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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013305
Receipt No. R000015519
Scientific Title Efficacy of once every four week oral minodronate in patients with glucocorticoid-induced osteoporosis after switching from weekly oral bisphosphonate
Date of disclosure of the study information 2014/02/28
Last modified on 2019/03/04

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Basic information
Public title Efficacy of once every four week oral minodronate in patients with glucocorticoid-induced osteoporosis after switching from weekly oral bisphosphonate
Acronym Efficacy of once every four week oral minodronate in patients with glucocorticoid-induced osteoporosis
Scientific Title Efficacy of once every four week oral minodronate in patients with glucocorticoid-induced osteoporosis after switching from weekly oral bisphosphonate
Scientific Title:Acronym Efficacy of once every four week oral minodronate in patients with glucocorticoid-induced osteoporosis
Region
Japan

Condition
Condition Glucocorticoid-induced osteoporosis
Classification by specialty
Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine usability and efficacy of once every four week oral minodronate in patients with glucocorticoid-induced osteoporosis after switching from weekly oral bisphosphonate
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Patients' satisfaction regarding medication at the week 24 and the week 52 after random allocation
Key secondary outcomes Changes in bone mineral density and bone metabolic markers at the week 24 and the week 52 after random allocation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Minodronate 50mg tablet (once every 4 weeks)
Interventions/Control_2 Weekly bisphosphonate tablet (alendronate 35 mg or risedronate 17.5 mg tablet)
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) Pateints with following rheumatic disease or connective tissue disease, such as rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, Sjogren's syndrome, mixed connective tissue disease, vasculitis syndrome, Behcet disease, and polymyalgoa rheumatica.
2) Patients who has been treated with corticosteroid at average dose more than 5 mg/day prednisolone equivalent for the last 3 months.
3) Patients who has been treated with weekly oral bisphosphonate, such as alentronate or risedronate.
Key exclusion criteria 1) Patients with esophageal dysmortility, such as esophageal constriction or achalasia.
2) Patients who could not stay upright position after taking medicine.
3) Patients who had allergic reaction to bisphosphonate.
4) Patients with hypocalcemia.
5) Patients who is presently breast-feeding, is pregnant, is suspected to be pregnant, or cannot use birth control during the study period.
6) Patients who are receiving bisphosphonate other than oral weekly bisphosphonate, teriparatide, or denosumab.
7) Patients who are planning to receive dental extraction in the enrollment period.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taio Naniwa
Organization Nagoya City University Hospital
Division name Department of Rheumatology
Zip code
Address Kawasumi 1, Mizuho-ku, Nagoya, Aichi, Japan
TEL 052-851-5511
Email tnaniwa@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taio Naniwa
Organization Nagoya City University Hospital
Division name Department of Rheumatology
Zip code
Address Kawasumi 1, Mizuho-ku, Nagoya, Aichi, Japan
TEL 052-851-5511
Homepage URL
Email tnaniwa@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Medical Oncology and Immunology, Nagoya City University Graduate School of Medical Sciences.
Department of Rheumatology, Nagoya City University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 名古屋市立大学病院

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 28 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 No longer recruiting
Date of protocol fixation
2013 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 25 Day
Last follow-up date
2017 Year 04 Month 30 Day
Date of closure to data entry
2017 Year 04 Month 30 Day
Date trial data considered complete
2017 Year 04 Month 30 Day
Date analysis concluded
2017 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 28 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015519

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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