UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on Factors Osteoporosis Quality-of-life in Japanese Subjects
Title of the study (Brief title)	Study on Factors Osteoporosis Quality-of-life in Japanese Subjects
Region	Japan

Condition
Condition	Osteoporpsis
Classification by specialty	Medicine in general Clinical immunology Obsterics and gynecology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This is an observationall study and patient questionnaire to investigate quality of life (QOL) and pain management in Japanese osteoporosis patients who have started osteoporosis treatment (bisphosphonate).
Basic objectives2	Others
Basic objectives -Others	This is an observationall study and patient questionnaire to investigate quality of life (QOL) and pain management in Japanese osteoporosis patients who have started osteoporosis treatment (bisphosphonate).
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	QOL,compliance
Key secondary outcomes	Pain, BMD

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	55 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	As follows: 1) Japanese women of 55years old or older 2) Patients diagnosed as osteoporosis 3) Patients who have initiated osteoporosis treatment (bisphosphonate) in the past 30days 4) Patients who can fill out the patientquestionnaire adequately after granting informed consent
Key exclusion criteria	1) Women under 55 years old of age 2) Patients who have ever experienced any bisphosphonate treatment within the last 6 months from the date of initiating bisphosphonate 3) Patients already participating in other osteoporosis related clinical trials for the purpose of regulatory approval at the time of enrollment
Target sample size	6000

Research contact person
Name of lead principal investigator	Toshitaka Nakamura
Organization	UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH, JAPAN
Division name	Orthopedic surgery, professor
Address	1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL	093-603-1611
Email	k-ishii@apoplus.co.jp

Public contact
Name of contact person	kiyomi ishii
Organization	APO PLUS STATION Co.,LTD
Division name	Clinical Study Dept.CRO Business Div
Address	2-14-1,Nihonbashi,Chuo-ku,Tokyo 103-0027 Japan
TEL	03-6386-8800
Homepage URL
Email	k-ishii@apoplus.co.jp

Sponsor
Institute	Japan Association of Health Service
Institute
Department

Funding Source
Organization	Japan Association of Health Service
Organization
Division
Category of Funding Organization	Non profit foundation
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	2010 Year 04 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 09 Month 17 Day
Anticipated trial start date	2009 Year 10 Month 01 Day
Last follow-up date	2013 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2013 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	The study is a prospective multi-center observational study using medical record review and patient questionnaires to review QOL and pain management in Japanese osteoporosis patients receiving once-weekly bisphosphonate treatment. Osteoporosis patients already receiving once-weekly bisphosphonate treatment will be enrolled in the one year period from November 1, 2009 to October 31, 2009 with a two-year observational period from date of enrollment in order to review pain and QOL issues.

Management information
Registered date	2010 Year 04 Month 13 Day
Last modified on	2018 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004214