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Name:
UMIN ID:

Recruitment status Completed
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 2020/03/03

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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 Taio
Middle name
Last name Naniwa
Organization Nagoya City University Hospital
Division name Department of Rheumatology
Zip code 467-8601
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 Taio
Middle name
Last name Naniwa
Organization Nagoya City University Hospital
Division name Division of Rheumatology, Department of Internal Medicine
Zip code 467-8601
Address Kawasumi 1, Mizuho-ku, Nagoya, Aichi, Japan
TEL 0528538216
Homepage URL
Email tnaniwa@med.nagoya-cu.ac.jp

Sponsor
Institute Division of Rheumatology, Department of Internal Medicine, 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 Nagoya City University Hospital
Address Kawasumi, Mizuho-ku, Nagoya City, Aichi, Japan
Tel 052-851-5511
Email clinical_research@med.nagoya-cu.ac.jp

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 https://link.springer.com/article/10.1007%2Fs11657-018-0451-7
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007%2Fs11657-018-0451-7
Number of participants that the trial has enrolled 145
Results
The proportions of patients responding very satisfactory or satisfactory
@week 48: switching group 45.9% vs continuing group 26.8%, difference 19.2% [95%CI 3.8 to 34.5], P=0.016
@week 76: switching group 44.6% vs continuing group 28.2%, difference 16.4% [ 1.0 to 31.8], P=0.040
Change in lumber spine BMD from week 24
@week 48: switching group 0.72% [ 0.00 to 1.44] vs continuing group -0.38% [ -1.31 to 0.56]
@week 76: switching group 0.88% [ 0.08 to 1.69] vs continuing group -0.60% [ -1.51 to 0.31]
Results date posted
2020 Year 03 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 06 Month 13 Day
Baseline Characteristics
Patients with systemic rheumatic diseases aged 20 years or more, who had to have been receiving systemic glucocorticoid treatment at an average prednisolone equivalent dose of 5 mg per day or more more than 3 months and weekly oral alendronate or risedronate tablets before screening (7 to 91 days before baseline) and baseline (week 0) visits. 
Patients were excluded if they were taking bisphosphonates other than weekly oral alendronate or risedronate tablets, or they had previously taken or were taking parathyroid hormone analogues, denosumab, or other investigational new drugs for the treatment of osteoporosis. 
Participant flow
Eligible participants underwent the initial 24-week run-in period (from weeks 0 to 24) taking a weekly oral 35 mg alendronate tablet or 17.5 mg risedronate tablet which are the approved dosages for osteoporosis treatment in Japan. Subsequently, patients were randomly assigned in a 1:1 ratio to one of the two treatment groups: the switching group, in which participants discontinued weekly bisphosphonate and started to receive an oral 50 mg minodronate tablet every four weeks (monthly minodronate) at week 24; or the continuing group, in which participants continued to receive a weekly oral bisphosphonate tablet (35 mg alendronate or 17.5 mg risedronate) for the subsequent 52-week randomization period (from week 24 to week 76).
Adverse events
Adverse events including upper gastrointestinal symptoms assessed by the Izumo Scale, vertebral fractures by thracic and lumber radiographs were collected.
Outcome measures
Primary endpoint
1. The difference between the proportions of patients who responded very satisfactory or satisfactory for the current bisphosphonate therapy at weeks 48 and 76 in the switching group and in the continuing group.
Secondary endpoints
1. Percent changes from week 24 in lumbar spine BMD and bone turnover markers at weeks 48 and 76.
2. Mean percentage changes from week 24 in BMD and bone turnover markers at weeks 48 and 76 within each treatment group. 
3. Incidence of vertebral and non-vertebral fractures
4. Incidence of upper gastrointestinal symptoms, adverse events, and adherence rates to the study drugs at weeks 24, 48, and 76.
5. Average doses of glucocorticoids calculated during the three months before study entry, weeks 1 to 24, weeks 25 to 48, and weeks 49 to 76. 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 09 Month 11 Day
Date of IRB
2013 Year 10 Month 07 Day
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
2020 Year 03 Month 03 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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