UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000001
Receipt No. R000000002
Scientific Title Concurrent Treatment of Osteoporosis for Prevention of Vertebral Fracture in Japan - Multi-center Randomized Trial with Arendoronate and alfa-calcidol -
Date of disclosure of the study information 2005/07/01
Last modified on 2008/12/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Concurrent Treatment of Osteoporosis for Prevention of Vertebral Fracture in Japan
- Multi-center Randomized Trial with Arendoronate and alfa-calcidol -
Acronym Japanese Osteoporosis Intervention Trial (JOINT) -02
Scientific Title Concurrent Treatment of Osteoporosis for Prevention of Vertebral Fracture in Japan
- Multi-center Randomized Trial with Arendoronate and alfa-calcidol -
Scientific Title:Acronym Japanese Osteoporosis Intervention Trial (JOINT) -02
Region
Japan

Condition
Condition Osteoporosis
Classification by specialty
Endocrinology and Metabolism Geriatrics Obsterics and gynecology
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the clinical significant of concurrent use of active vitaminD to alendronate by incident vertebral fracture rate as index.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incident vertebral fracture rate
Key secondary outcomes Period of incident vertebral fracture, non-vertebvral fracture rate, bone mineral density, QOL, Sreum vitamin D, safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 alendronate(2years)
Interventions/Control_2 alendronate+active vitaminD3(2years)
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
70 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria osteoporosis, prevalent vertebral fracture number=<4, >=70year women, possible to walk alone, risk foctor number of incident vertebral fracture=>1,possible to answer QOL questionnaire
Key exclusion criteria Bone disease other than osteoporosis, having contraindication in using drugs, disfunction of communication of the intention, deformation of vertebra, hyperthyroidism, hyperparathyroidism, abnormal heart function, abnormal hepatic function, abnormal kidney function, taken bisphosponate within previous 6 months
Target sample size 2140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Orimo
Organization Health science university
Division name President
Zip code
Address Kawaguchiko-cho, tsuru-gun, Yamanashi, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Public health research foundation
Division name CSP-A-TOP
Zip code
Address 1-1-7 Nishi-waseda, Shinjyuku-ku Tokyo, Japan
TEL 03-5287-2633
Homepage URL http://www.a-top.jp
Email a-top@csp.or.jp

Sponsor
Institute Japan Osteoporosis Society/ A-TOP consortium
Institute
Department

Funding Source
Organization Public health research foundation
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
Email

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
2005 Year 07 Month 01 Day

Related information
URL releasing protocol http://www.a-top.jp
Publication of results Unpublished

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 No longer recruiting
Date of protocol fixation
2003 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2003 Year 11 Month 01 Day
Last follow-up date
2008 Year 06 Month 01 Day
Date of closure to data entry
2008 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 06 Month 01 Day
Last modified on
2008 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000002

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.