UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003481 |
|---|---|
| Receipt number | R000004214 |
| Scientific Title | Study on Factors Osteoporosis Quality-of-life in Japanese Subjects |
| Date of disclosure of the study information | 2010/04/13 |
| Last modified on | 2018/08/22 19:12:39 |
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Basic information
Public title
Study on Factors Osteoporosis Quality-of-life in Japanese Subjects
Acronym
Study on Factors Osteoporosis Quality-of-life in Japanese Subjects
Scientific Title
Study on Factors Osteoporosis Quality-of-life in Japanese Subjects
Scientific Title:Acronym
Study on Factors Osteoporosis Quality-of-life in Japanese Subjects
Region
| Japan |
Condition
Condition
Osteoporpsis
Classification by specialty
| Medicine in general | Clinical immunology | Obstetrics 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
| 1st name | |
| Middle name | |
| Last name | Toshitaka Nakamura |
Organization
UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH, JAPAN
Division name
Orthopedic surgery, professor
Zip code
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL
093-603-1611
k-ishii@apoplus.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kiyomi ishii |
Organization
APO PLUS STATION Co.,LTD
Division name
Clinical Study Dept.CRO Business Div
Zip code
Address
2-14-1,Nihonbashi,Chuo-ku,Tokyo 103-0027 Japan
TEL
03-6386-8800
Homepage URL
k-ishii@apoplus.co.jp
Sponsor or person
Institute
Japan Association of Health Service
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2009 | Year | 09 | Month | 17 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004214
