UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013001 |
|---|---|
| Receipt number | R000014987 |
| Scientific Title | Influence of the intravenous drip infusion of alendronate on healing of proximal femoral fracture |
| Date of disclosure of the study information | 2014/01/29 |
| Last modified on | 2014/01/29 00:57:20 |
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Basic information
Public title
Influence of the intravenous drip infusion of alendronate on healing of proximal femoral fracture
Acronym
Influence of the intravenous drip infusion of alendronate on healing of proximal femoral fracture
Scientific Title
Influence of the intravenous drip infusion of alendronate on healing of proximal femoral fracture
Scientific Title:Acronym
Influence of the intravenous drip infusion of alendronate on healing of proximal femoral fracture
Region
| Japan |
Condition
Condition
osteoporosis
proximal femoral fracture
Classification by specialty
| Geriatrics | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the affect of drip infusion of alendronate on healing of proximal femoral fracture with osteoporosis before bony union
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of bony union until 48 weeks after surgical intervention
Key secondary outcomes
1. the time required for bony union after surgical intervention
2. quantitative change of bone density
3. quantitative change of bone metabolic markers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
alendronate with Alfacalcidol
Interventions/Control_2
Alfacalcidol without alendronate
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients with osteoporosis
2. proximal femoral fracture needs fracture fixation
Key exclusion criteria
1. subtrochanteric fracture
2. alendronate allergy
3. hypocalcemia
4. severe complication of cardiac, renal or hepatic function
5. systemic desease affects bone healing
6. inappropriate patient
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | tatsuya sato |
Organization
Asahikawa medical Univ.
Division name
Department of artificial joints
Zip code
Address
Midorigaoka-higashi 2-1-1-1, asahikawa, hokkaido
TEL
0166-68-2512
s-tatsu@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | tatsuya sato |
Organization
Asahikawa medical Univ.
Division name
Department of Artificial Joints
Zip code
Address
Midorigaoka-higashi 2-1-1-1, asahikawa, hokkaido
TEL
0166-68-2512
Homepage URL
s-tatsu@asahikawa-med.ac.jp
Sponsor or person
Institute
Orthopaedic department, Asahikawa Medical Univ.
Institute
Department
Personal name
Funding Source
Organization
Orthopaedic department, Asahikawa Medical Univ.
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
旭川医科大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 29 | Day |
Last modified on
| 2014 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014987
