UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000001 |
|---|---|
| Receipt number | 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 | 2023/07/03 15:13:28 |
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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 | Obstetrics 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 | Hajime |
| Middle name | |
| Last name | Orimo |
Organization
Japan Osteoporosis Foundation
Division name
President
Zip code
103-0011
Address
Nihonbashiodenmacho, Tyuuou ku, Tokyo, Japan
TEL
03-5640-1841
info@jpof.or.jp
Public contact
Name of contact person
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Kuroda |
Organization
Public health research foundation
Division name
CSP-A-TOP
Zip code
169-0051
Address
1-1-7 Nishi-waseda, Shinjyuku-ku Tokyo, Japan
TEL
03-5287-2633
Homepage URL
http://www.a-top.jp
a-top@csp.or.jp
Sponsor or person
Institute
Japan Osteoporosis Society/ A-TOP consortium
Institute
Department
Personal name
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
Public Health Research Foundation
Address
Nishiwaseda Shinjyuku Japan
Tel
03-5287-2638
a-top@csp.or.jp
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
Published
Result
URL related to results and publications
Current Medical Research and Opinion Vol 27, No.6, 2011, 1273-1284 URL https://doi.org/10.1185/03007
Number of participants that the trial has enrolled
2164
Results
The combination therapy was no more effective for overall vertebral fracture prevention. However, subgroup analysis has shown that it was more effective for fracture prevention in patients with severe vertebral deformity, multiple prevalent vertebral fractures, and for non-vertebral weight-bearing bone fracture prevention.
Results date posted
| 2023 | Year | 07 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eligible patients were postmenopausal women with severe osteoporosis who were aged 70 years or older and had several risk factors for incident fractures.
Participant flow
A total of 2164 patients(combination therapy group, 1081; monotherapy group, 1083) were enrolled in this trial, and the authors analyzed the remaining 2022 patients(combination therapy group, 995; monotherapy group, 1027) as the FAS.
Adverse events
Although one patient given the combination therapy had mild hypercalcemia, serious hypercalcemia and unknown adverse events were not encountered.
Outcome measures
The primary endpoint was prevention of incident fractures, and the anti-fracture efficacy was evaluated in relation to the baseline serum 25(OH)D level.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2003 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2003 | Year | 11 | Month | 01 | Day |
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
| 2023 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000002
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