UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Patient preference for monthly bisphosphonate versus weekly bisphosphonate in a cluster-randomized, open-label, crossover trial
Title of the study (Brief title)	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	Jun Iwamoto
Organization	Keio University School of Medicine
Division name	Institute for Integrated Sports Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	jiwamotoexmed@gmail.com

Public contact
Name of contact person	Jun Iwamoto
Organization	Keio University School of Medicine
Division name	Institute for Integrated Sports Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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