UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018492 |
|---|---|
| Receipt number | R000019629 |
| Scientific Title | Effect of minodronate for preventring secondary fragility fractures in postoperative hip fractures of oseteoporotic patients. |
| Date of disclosure of the study information | 2015/08/15 |
| Last modified on | 2015/07/30 16:55:45 |
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Basic information
Public title
Effect of minodronate for preventring secondary fragility fractures in postoperative hip fractures of oseteoporotic patients.
Acronym
Effect of minodronate for preventring secondary fragility fractures in postoperative hip fractures of oseteoporotic patients.
Scientific Title
Effect of minodronate for preventring secondary fragility fractures in postoperative hip fractures of oseteoporotic patients.
Scientific Title:Acronym
Effect of minodronate for preventring secondary fragility fractures in postoperative hip fractures of oseteoporotic patients.
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of minodronate 50mg once 4 weeks for preventing secondary fragility fractures and increasing bone mineral density in postoperative hip fractures of osteoporotic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Incidence rate of osteoporotic fragility fracture.
2. Percentage change in lumbar spine and proximal femoral bone mineral density
Key secondary outcomes
1. Serum bone resorption marker (TRACP-5b: Tartrate resistant acid phosphatase-5b)
2. Serum bone formation marker (P1NP: aminoterminal propeptide of type I collagen)
3. Serum bone matrix marker (Homocysteine, Pentosidine)
4. Change of laboratory values (Ca, AST, ALT, ALP, serum creatinine, and so on.)
5. Improvement of QOL (SF-8)
6. Medication persistence rate of minodronate and incidence rate of adverse event.
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
minodronate 50mg once 4 weeks(min group)
Interventions/Control_2
no treatment of minedronate (control)
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese osteoporotic patients who aged over 50 years old, who was postoperative fragility hip fracture, and who provided consent to participate in the study.
Key exclusion criteria
1. Have 3 or more vertebral fractures between L1 and L4 or history of hip fracture.
2. Have peptic ulcers.
3. Have history of gastrectomy or broad gastrointestinal resection.
4. Have diseases that are likely to delay esophageal transit such as esophagus stenosis or achalasia.
5. Cannot keep upright or sitting positioning for 30 minutes or more which taking drug.
6. Have history of severe drug allergy of minodronate or eldecalcitol.
7. Have corrected serum calcium on the latest laboratory result.
8. Have severe hepatic and renal dysfunction and cardiovascular disease.
9. Pregnant females or females who plan to be pregnant.
10. Judged inappropriate to participate the study by attending physicians.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Hayashi |
Organization
Nagano Red Cross Hospital
Division name
orthopaedics
Zip code
Address
5-22-1 Wakasato Nagano Japan
TEL
026-226-4131
hayashimasatoshi@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatoshi Hayashi |
Organization
Nagano Red Cross Hospital
Division name
orthopaedics
Zip code
Address
5-22-1 Wakasato Nagano Japan
TEL
026-226-4131
Homepage URL
hayashimasatoshi@hotmail.com
Sponsor or person
Institute
Nagano Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
no funding
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 08 | Month | 15 | 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
| 2015 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 30 | Day |
Last modified on
| 2015 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019629
