UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013305 |
|---|---|
| Receipt number | 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 19:43:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tnaniwa@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Division of Rheumatology, Department of Internal Medicine, Nagoya City University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
