UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of minodronic acid hydrate in patients with osteoporosis
Title of the study (Brief title)	Efficacy of minodronic acid hydrate in patients with osteoporosis
Region	Japan

Condition
Condition	osteoporosis
Classification by specialty	Obsterics and gynecology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of y minodronic acid hydrate (MIN) in both naive and other bisphosphonates-treatment resistant osteoporotic patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1)Newly diagnosed Osteoporotic patients -Changes in bone metabolic markers -Changes in QOL score(SF-8) (2) Other bisphosphonates-treatment resistant osteoporotic patients. -Changes in bone mineral density -Changes in hip structure analysis
Key secondary outcomes	(1)Newly diagnosed Osteoporotic patients -Correlation between bone metabolic markers -Correlation between the number of incident fracture and the efficacy of MIN -Incidence of new vertebral fracture -Adherence to MIN - Incidence of side effects (2) Other bisphosphonates-treatment resistant osteoporotic patients. -Changes in bone metabolic markers -Correlation between bone metabolic markers and bone mineral density -Correlation between the number of incident fracture and the efficacy of MIN -Incidence of new vertebral fracture -Adherence to MIN - Incidence of side effects

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients included are to be given minodronic acid hydrate
Interventions/Control_2
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 take bisphosphonates more than 2 years and do not gain the bone mineral density (lumbar vertebra or hip) over 3 % since prescription of bisphosphonates 3)Age-lower limit: 50 years old, age-higher limit: none 4)Patients able to walk themselves 5)Patients giving informed consent
Key exclusion criteria	1)Secondary osteoporotic patient 2)Patients with peptic ulcers 3)Patients with history of gastrectomy or broad gastrointestinal resection 4)Patients who diagnosed malignancy 4)Patients with obstacles which delays esophagus passage of stricture of the esophagus or achalasia 5) Patients who have raised the upper part of the body for 30 minutes or it cannot be standing 6) Patients with hypersensitivity to bisphosphonates 7)Patients with receiving therapy of SERM or bisphosphonates 8)Patients with receiving therapy of drugs affecting bone metabolism within 8 weeks before study 9)Patients with hypocalcemia 10)Patients with severe hepatic and renal dusfunction and cardiovascular disease 11)Patients with pregnancy
Target sample size	120

Research contact person
Name of lead principal investigator	Hiroshi Hagino
Organization	Tottori University
Division name	Faculty of Medicine, School of Health Science
Address	86 Nishimachi, Yonago-shi, Tottori, Japan
TEL	0859-38-6308
Email	hagino@med.tottori-u.ac.jp

Public contact
Name of contact person	Hiroshi Hagino
Organization	Tottori University
Division name	School of Health Science, Faculty of Medicine
Address	86 Nishimachi, Yonago-shi, Tottori, Japan
TEL	0859-38-6308
Homepage URL
Email	hagino@med.tottori-u.ac.jp

Sponsor
Institute	Tottori University, Faculty of Medicine, School of Health Science
Institute
Department

Funding Source
Organization	Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 28 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2016 Year 01 Month 18 Day

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

Management information
Registered date	2013 Year 09 Month 24 Day
Last modified on	2018 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013846