UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of monthly minodronate versus weekly bisphosphonate on bone mineral density in women with postmenopausal osteoporosis
Title of the study (Brief title)	Comparison of monthly minodronate versus weekly bisphosphonate on bone mineral density in women with postmenopausal osteoporosis
Region	Japan

Condition
Condition	Osteoporosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Bone mineral density and bone turnover marker are evaluated for once-monthly (4-weekly) versus once-weekly bisphosphonate in women with postmenopausal osteoporosis. This is a 24-week prospective, randomized, open-label, multicenter trial with a two-period and two-sequence crossover treatment design. Further, patient preferences, quality of life and VAS are assessed for both regimens.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change L2-4 BMD using DXA and bone turnover maker (TRACP-5b) are analyzed separately for baseline to 24-week and 48-week.
Key secondary outcomes	QOL and VAS are measured at baseline , 24-week and 48-week after treatment. Patient preference is assessed at 48 weeks after treatment.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Test drug (24 weeks),Control drug (24 weeks) [Test drug (once 4-weekly BP)] Minodronic acid hydrate (Recalbon or Bonoteo tablets) 50mg [Control drug (once-weekly BP)] Alendronate tablets 35mg or risedronate tablets 17.5mg
Interventions/Control_2	Control drug (24 weeks),Test drug (24 weeks) [Control drug (once-weekly BP)] Alendronate tablets 35mg or risedronate tablets 17.5mg [Test drug (once 4-weekly BP)] Minodronic acid hydrate (Recalbon or Bonoteo tablets) 50mg
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	Not applicable
Gender	Female
Key inclusion criteria	1)Primary osteoporotic patients 2)Patients who did not take bisphosphonate more than 6 months before this trial 3)Age-lower limit: 50 years old, age-higher limit: none 4)Patients who passed after the menopause for two years or more before informed consent 5)Hospitalization/outpatient: no object
Key exclusion criteria	1)Secondary osteoporotic patient and patients who had disorders such as other causes of low bone mineral density 2)Patients who had history of gastrectomy or broad gastrointestinal resection 3)Patients who diagnosed malignancy 4)Patients who had history of radiation to lumber or pelvic section 5)Patients who had an observation affecting bone mineral density using DXA 6)Patients who received therapy of IV bisphosphonate 7)Patients who received therapy of strontium or parathyroid hormone 8)Patients who took calcitonin within a month before this trial 9)Patients who is receiving therapy of oral steroid 10)Patients who is receiving therapy of biologics or DMARDs 11)Patients who have obstacles which delays esophagus passage of stricture of the esophagus or achalasia 12)Patients who have raised the upper part of the body for 30 minutes or it cannot be standing 13)Patients who have serum calcium levels 10.6 or more mg/L 14)Patients who have serum calcium levels 8.0 or less mg/L 15)Patients who have severe renal dysfunction (creatinine clearance levels below 30 mL/min)
Target sample size	216

Research contact person
Name of lead principal investigator	Takashi Imagama
Organization	Yamaguchi university graduate school of medicine
Division name	Orthopedic Surgery
Address	1-1-1 minami-kogushi, ube, yamaguchi, Japan
TEL	0836-22-2266
Email	takaima@yamaguchi-u.ac.jp

Public contact
Name of contact person	Takashi Imagama
Organization	Yamaguchi university graduate school of medicine
Division name	Orthopedic Surgery
Address	1-1-1 minami-kogushi, ube, yamaguchi, Japan
TEL	0836-22-2266
Homepage URL
Email	takaima@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi university graduate school of medicine, Department of orthopedic surgery
Institute
Department

Funding Source
Organization	Ono Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	ONO PHARMACEUTICAL CO., LTD.
Name of secondary funｄer(s)	None

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	山口大学医学部附属病院（山口県）、山口労災病院（山口県）、周南記念病院（山口県）、関門医療センター（山口県）、山口県立総合医療センター（山口県）、徳山中央病院（山口県）、新南陽市民病院（山口県）、山陽小野田市民病院（山口県）、周東総合病院（山口県）、宇部記念病院（山口県）、長門総合病院（山口県）

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 28 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 04 Month 25 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 27 Day
Last modified on	2016 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009461