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Recruitment status
Unique ID issued by UMIN UMIN000025025
Receipt No. R000028799
Scientific Title Dose minodronic acid for patients of differentiated thyroid carcinoma with TSH suppressive therapy after total-thyroidectomy prevent osteoporosis?
Date of disclosure of the study information 2016/11/28
Last modified on 2016/11/28

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Basic information
Public title Dose minodronic acid for patients of differentiated thyroid carcinoma with TSH suppressive therapy after total-thyroidectomy prevent osteoporosis?
Acronym M.D.T Trial
Scientific Title Dose minodronic acid for patients of differentiated thyroid carcinoma with TSH suppressive therapy after total-thyroidectomy prevent osteoporosis?
Scientific Title:Acronym M.D.T Trial
Region
Japan

Condition
Condition Patients of differentiated thyroid carcinoma after total-thyroidectomy
Classification by specialty
Endocrine surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to investigate efficacy that minodronic acid prevent osteoporosis for patients of diffrentiated thyroid carcinoma with TSH suppressive therapy after total-thyroidectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Bone mineral density of the lumbar vertebra and unilateral thigh bone( 6 month, 12month after administration)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 minodronic acid
Interventions/Control_2 alfa calcidol
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Female
Key inclusion criteria 1.Diagnosis of differentiated thyroid carcinoma by pathological examination
2.postmenopausal female
3.
A:TSH <0.44ng/ml
B:Serum calcium level 8.5~10.5mg/dl
C:eGFR > 60ml/min
Key exclusion criteria 1.bone fracture before thyroidectomy
2.family history of thighbone fracture
3.Administration of bisphosphonate before thyrodectomy
4.hyper-parathyroidism
5.hypo-parathyroidism after thyroidectomy
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chikara Kagawa
Organization Fujita-health University
Division name Endocrine Surgery
Zip code
Address 1-98 Denrakugakubo, Kustukake-cho, Toyoake,Aichi
TEL 0562-93-9033
Email chikarak@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chikara Kagawa
Organization Fujita-health University
Division name Endocrine Surgery
Zip code
Address 1-98 Denrakugakubo, Kustukake-cho, Toyoake,Aichi
TEL 0562-93-9033
Homepage URL
Email chikarak@fujita-hu.ac.jp

Sponsor
Institute Department of Endocrine Surgery,Fujita-health University
Institute
Department

Funding Source
Organization Department of Endocrine Surgery,Fujita-health University
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 藤田保健衛生大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 28 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
Date of protocol fixation
2016 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 28 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
2016 Year 11 Month 28 Day
Last modified on
2016 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028799

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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