UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025025 |
|---|---|
| Receipt number | 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 19:25:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
chikarak@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Endocrine Surgery,Fujita-health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028799
