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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024211
Receipt No. 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

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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
Email 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
Email jiwamotoexmed@gmail.com

Sponsor
Institute Clinical practice-based osteoporosis conference
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027868

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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