UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008783 |
|---|---|
| Receipt number | R000010323 |
| Scientific Title | Prospective study to determine the effect of bisphosphonate and SERM on bone markers in postmenopausal women with osteoporosis and type 2 diabetes. |
| Date of disclosure of the study information | 2012/08/28 |
| Last modified on | 2014/03/28 12:05:56 |
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Basic information
Public title
Prospective study to determine the effect of bisphosphonate and SERM on bone markers in postmenopausal women with osteoporosis and type 2 diabetes.
Acronym
The effect of bisphosphonate and SERM in postmenopausal women with osteoporosis and type 2 diabetes.
Scientific Title
Prospective study to determine the effect of bisphosphonate and SERM on bone markers in postmenopausal women with osteoporosis and type 2 diabetes.
Scientific Title:Acronym
The effect of bisphosphonate and SERM in postmenopausal women with osteoporosis and type 2 diabetes.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the change of bone markers by treatment of osteoporosis (bisphosphonate or SERM) in postmenopausal women with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
changes of serum pentosidine levels after six months of treatment of osteoporosis.
Key secondary outcomes
change sof serum bone markers levels , bone density of lumbus and femur neck, FRAX, HbA1c and the general blood test after six months of treatment of osteoporosis.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 55 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Postmenopausal women.
Patients of type 2 diabetes whose HbA1c(NGSP)is less than 10%.
Patients who fit criteria for medication in guideline for preservation and medication of osteoporosis 2011.
Patients whose treatment for diabetes has not been changed for more than 4 weeks when they entry this study.
Patients who agreed with written consent form, receiving enough information of this study.
Key exclusion criteria
Patients who don't agreed with written consent form.
Patients who are expected to change hypoglycemic agents, especially pioglitazone and incretin-based therapies, during observation period.
Patients who have been treated with
Bisphosphonate, SERM or PTH within 6 months.
Patients who are suited for contraindications of bisphosphonate and SERM.
Patients who are inappropriate for this study by research director.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki, Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Medicine II
Zip code
Address
N-14, W-5, Kita-Ku, Sapporo, 060-8638, Japan
TEL
011-706-5915
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki, Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Medicine II
Zip code
Address
N-14, W-5, Kita-Ku, Sapporo, 060-8638, Japan
TEL
011-706-5915
Homepage URL
http://www.huhp.hokudai.ac.jp/patient/clinical/clinical.html
hmiyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Medicine II, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
http://www.huhp.hokudai.ac.jp/patient/clinical/clinical.html
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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2014 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 20 | Day |
Other
Other related information
Prospective study
Management information
Registered date
| 2012 | Year | 08 | Month | 28 | Day |
Last modified on
| 2014 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010323
