UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000838 |
|---|---|
| Receipt number | R000001003 |
| Scientific Title | Multi-centric randomized open-label comparative study for influence of bisphosphonate on fracture healing in patients with spinal compression fractures or femoral neck fractures |
| Date of disclosure of the study information | 2007/10/01 |
| Last modified on | 2012/10/01 19:12:26 |
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Basic information
Public title
Multi-centric randomized open-label comparative study for influence of bisphosphonate on fracture healing in patients with spinal compression fractures or femoral neck fractures
Acronym
Influence of bisphosphonate on spinal compression fractures or femoral neck fractures
Scientific Title
Multi-centric randomized open-label comparative study for influence of bisphosphonate on fracture healing in patients with spinal compression fractures or femoral neck fractures
Scientific Title:Acronym
Influence of bisphosphonate on spinal compression fractures or femoral neck fractures
Region
| Japan |
Condition
Condition
Osteoporotic spinal compression fractures and femoral neck fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the difference of the influence of sodium risedronate hydrate on fracture healing in patients with spinal compression fracture or femoral neck fracture depending on the starting point of the medication.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fracture healing is assessed with X ray film and computed tomograhy, and QOL is assessed with questionnaires.
Key secondary outcomes
Bone mineral density, visual analogue scale and bone markers are measured.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sodium risedronate hydrate was given from 1 week after injury or surgery in group A.
Interventions/Control_2
Sodium risedronate hydrate was given from 3 months after injury or surgery in group B.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria are primary osteoporosis patients with the age of 65 to 90 years old, osteoporotic spinal compression fractures, and osteoporotic femoral neck fractures.
Key exclusion criteria
Exclusion criteria are patients treated with bisphosphonate within 3 months, fractures resulted from high energy trauma, patients contraindicant to bisphosphonate, and patients judged inadequate to include this study by doctors.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Ozeki |
Organization
Dokkyo Medical University Koshigaya Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-1-50 Minami-Koshigaya, Koshigaya, Saitama, Japan
TEL
048-965-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Iida |
Organization
Dokkyo Medical University Koshigaya Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-1-50 Minami-Koshigaya, Koshigaya, Saitama, Japan
TEL
048-965-1111
Homepage URL
takiida@dokkyomed.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Dokkyo Medical University Koshigaya Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Dokkyo Medical University Koshigaya Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2007 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
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
Completed
Date of protocol fixation
| 2007 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 09 | Month | 30 | Day |
Last modified on
| 2012 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001003
