UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000991 |
|---|---|
| Receipt number | R000001194 |
| Scientific Title | Prevention of incident fracture of Osteoporosis in Japan(Multi-center Randomized Trial with Risedronate and VitaminK2) |
| Date of disclosure of the study information | 2008/02/01 |
| Last modified on | 2021/06/01 11:21:02 |
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Basic information
Public title
Prevention of incident fracture of Osteoporosis in Japan(Multi-center Randomized Trial with Risedronate and VitaminK2)
Acronym
Japanese Osteoporosis Intervention Trial -03 (JOINT-03)
Scientific Title
Prevention of incident fracture of Osteoporosis in Japan(Multi-center Randomized Trial with Risedronate and VitaminK2)
Scientific Title:Acronym
Japanese Osteoporosis Intervention Trial -03 (JOINT-03)
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 significance of concurrent use of vitaminK2 to risedronate by incident vertebral fracture rate and incident nonvertebral 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 and incident nonvertebral fracture rate
Key secondary outcomes
Bone mineral density,stature,QOL, undercarboxylated osteocalcin,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
Risedronate(2 years)
Interventions/Control_2
Risedronate +vitaminK2(2 years)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Criteria for initiation of pharmacotherapy to prevent fragility fracture(Japanese Guidelines for the prevention and treatment of osteoporosis 2006 edition)
2.Age>=65 years old(female)
3.Risk factor number for incident fracture>=1(in A-TOP research group)
4.Possible to walk alone
5.Possible to answer QOL questionnaire
Key exclusion criteria
1.Using warfarin
2.Secondary osteoporosis and low bone mass disease except osteoporosis
3.Having contraindication in using drugs
4.Hypothyroidism and hyperparathyroidism
5.Disfunction of communication of the intention
6.Prevalent vertebral fracture>=6
7.Deformation of vertebra
8.Abnormal heart function,abnormal hepatic function,abnormal kidney function
9.Taken bisphosphonate within previous 6 months
Target sample size
1820
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
1030011
Address
2-14, Nihonbashi-odenmatyo, Tyuo-ku, Tokyo, Japan
TEL
03-5640-1841
info@jpof.or.jp
Public contact
Name of contact person
| 1st name | Yoji |
| Middle name | |
| Last name | Mitadera |
Organization
Public health research foundation
Division name
CSP-A-TOP
Zip code
1690051
Address
1-1-7,Nishiwaseda,Shinjuku-ku,Tokyo,Japan
TEL
03-5287-2638
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
-
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
| 2008 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.a-top.jp/
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00774-016-0768-5
Number of participants that the trial has enrolled
1983
Results
Concurrent treatment with vitamin K2 and risedronate was not efficacious compared with monotherapy with risedronate in terms of fracture prevention.
Results date posted
| 2021 | Year | 05 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2016 | Year | 08 | Month | 02 | Day |
Baseline Characteristics
The baseline characteristics of the patients in the FAS were well balanced between the two groups. The mean age of the patients was 75.3 years. About 54 % of patients had BMD less than YAM - 3 SD and about 70% of patients did not receive osteoporosis treatment during past 1 year. Half of patients had ucOC level less than 4.5 ng/mL.
Participant flow
A total of 1983 patients from 123 institutes in Japan were randomized and 931 patients in the risedronate and vitamin K2 group and 943 in the risedronate alone group were included the FAS after excluding those who did not receive treatment and those who were not eligible.
Adverse events
Adverse events occurred in 80 patients (83 reports) in the risedronate and vitamin K2 group and in 52 patients (54 reports) in the risedronate alone group. All adverse drug reactions were known and the most common adverse drug reactions were gastrointestinal disorders (4.05% in the risedronate and vitamin K2 group and 2.56% in the risedronate alone group). Serious adverse events occurred in 14 patients (14 reports) including 7 patients who died in the risedronate and vitamin K2 group and in 16 patients (16 reports) including 12 patients who died in the risedronate alone group and the included 3 adverse drug reactions (2 patients in the risedronate and vitamin K2 group and 1 patient in the risedronate alone group).
Outcome measures
The primary end point was the incidence of any fracture (vertebral and nonvertebral). The secondary end points were bone mineral density, height, undercarboxylated osteocalcin concentration, quality of life, and safety.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2007 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 22 | Day |
Last modified on
| 2021 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001194
