UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024211 |
|---|---|
| Receipt number | R000027868 |
| Scientific Title | Patient preference for monthly bisphosphonate versus weekly bisphosphonate in a cluster-randomized, open-label, crossover trial |
| Date of disclosure of the study information | 2016/09/29 |
| Last modified on | 2016/09/28 20:08:47 |
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Basic information
Public title
Patient preference for monthly bisphosphonate versus weekly bisphosphonate in a cluster-randomized, open-label, crossover trial
Acronym
Patient preference for monthly bisphosphonate versus weekly bisphosphonate
Scientific Title
Patient preference for monthly bisphosphonate versus weekly bisphosphonate in a cluster-randomized, open-label, crossover trial
Scientific Title:Acronym
Patient preference for monthly bisphosphonate versus weekly bisphosphonate
Region
| Japan |
Condition
Condition
Patients with primary osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the preference of Japanese patients with osteoporosis for monthly bisphosphonate and weekly bisphosphonate
Basic objectives2
Others
Basic objectives -Others
To test the convenience for monthly bisphosphonate and weekly bisphosphonate among Japanese patients with osteoporosis
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Patient preference for either monthly bisphosphonate regimen or weekly bisphosphonate regimen among patients responding to the questionnaire after 6-month of treatment with monthly bisphosphonate (3-month) and weekly bisphosphonate (3-month)
Key secondary outcomes
Convenience of monthly bisphosphonate regimen compared tih weekly bisphosphonate regimen among patients responding to the questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The clinics were randomized into two groups according to the dosing protocol, monthly bisphosphonate (3 months) followed by weekly bisphosphonate (3 months) or weekly bisphosphonate (3 months) followed by monthly bisphosphonate (3 months)
Interventions/Control_2
Monthly bisphosphonate: minodronate (50mg), weekly bisphosphonate: alendronate (35mg) or risedronate (17.5mg)
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
| 50 | years-old | < |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were age more than 50 years, a fully ambulatory status, a diagnosis of primary osteoporosis according to the Japanese diagnostic criteria and an osteoporosis treatment-naive status.
Key exclusion criteria
The exclusion criteria were a history of reflux esophagitis, gastric or duodenal ulcer, gastrectomy, renal failure, or bone diseases including cancer-induced bone loss, primary hyperparathyroidism, hyperthyroidism, Cushing syndrome, multiple myeloma, Paget's disease of the bone, rheumatoid arthritis, or osteogenesis imperfecta.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Iwamoto |
Organization
Keio University School of Medicine
Division name
Institute for Integrated Sports Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
jiwamotoexmed@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Iwamoto |
Organization
Keio University School of Medicine
Division name
Institute for Integrated Sports Medicine
Zip code
Address
35 Shinanomchi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
jiwamotoexmed@gmail.com
Sponsor or person
Institute
Clinical practice-based osteoporosis conference
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan INC.
Organization
Division
Category of Funding Organization
Non profit foundation
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
東京都の病院およびクリニック
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 07 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 28 | Day |
Last modified on
| 2016 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027868
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
