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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018492
Receipt No. 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

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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
Email 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
Email hayashimasatoshi@hotmail.com

Sponsor
Institute Nagano Red Cross Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019629

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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