UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010074 |
|---|---|
| Receipt number | R000011798 |
| Scientific Title | An exploratory assessment of the effect of bazedoxifene on glucose metabolism and bone quality in postmenopausal women with type 2 diabetes. |
| Date of disclosure of the study information | 2013/02/20 |
| Last modified on | 2014/09/21 12:51:02 |
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Basic information
Public title
An exploratory assessment of the effect of bazedoxifene on glucose metabolism and bone quality in postmenopausal women with type 2 diabetes.
Acronym
An exploratory assessment of the effect of bazedoxifene on glucose metabolism and bone quality in postmenopausal women with type 2 diabetes.
Scientific Title
An exploratory assessment of the effect of bazedoxifene on glucose metabolism and bone quality in postmenopausal women with type 2 diabetes.
Scientific Title:Acronym
An exploratory assessment of the effect of bazedoxifene on glucose metabolism and bone quality in postmenopausal women with type 2 diabetes.
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.The study of the effect that bazedoxifene gives on the serum levels of adiponectin and glucose metabolism markers in postmenopausal patients with type 2 diabetes.
2.The study of the effect that bazedoxifene gives on bone quality and bone resorption in postmenopausal patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes to be shown in levels of serum adiponectin during the period from the start of medication to the last medication after 12 weeks.
Key secondary outcomes
1.Changes to be shown on glucose metabolism markers, such as FPG, HbA1c (NGSP), IRI, s-CPR during the period from the start of medication to the last medeication after 12 weeks.
2.Changes to be shown on the bone quality markers, such as s-homocysteine, s-pentosidine, and also on the bone metabolism markers, such as TRAP-5b, u-CTX, NTX, osteocalcin, ucOC during the period from the start of medication to the last medeication after 12 weeks.
3.Changes to be shown on biochemical markers, such as TC, LDL-C, TG, HDL-C, hsCRP, ferritin, s-Cr, cystatin C during the period from the start of medication to the last medeication after 12 weeks.
4.Changes to be shown on the PWV during the period from the start of medication to the last medeication after 12 weeks.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral medication of bazedoxifene(20mg/day).
Taking blood and urine samples at 0, 4, 8 and 12 weeks after administration of the bazedoxifene.
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Female
Key inclusion criteria
1.The type 2 diabetes patients under 85 years of age with the interval of 2 years after the menopause.
2.HbA1c fluctuation is less than 0.5% for the past 12 weeks.
3.HbA1c level is less than 8.4%(NGSP).
4.Body Mass Index is less than 30.
5.Renal function is more than eGFR 30 ml/min/1.73m2.
6.Neither a new start nor alteration of medication is required for treatment of diabetes during the period from 4 weeks before the start of administration of bazedoxifene to 12 weeks after the administration.
7. Neither a new start nor alteration of medication is required for treatment by use of ACE-I, ARB, Statin, PPI during the period from 4 weeks before the start of administration of bazedoxifene to 12 weeks after the administration.
8.Signed written informed consent.
Key exclusion criteria
1.Past history of bone fractures related to non-traumatic accident.
2.Current use of pioglitazone (regardless of treatment duration).
3.Current use of steroid hormones (regardless of treatment duration).
4.The patients with the thyroid function abnormality for which treatment is needed.
5.Current use of other medications for osteoporosis:
Vitamin D: within 12 weeks after the suspension of administration.
Vitamin K2:within 12 weeks after the suspension of administration.
Bisphosphonates:within 24 weeks after the suspension of administration.
The others SERM(raloxifene):within 24 weeks after the suspension of administration.
PTH:within 24 weeks after the suspension of administration.
6.Past history of deep vein thrombosis.
7.Cancer bearing patients.
8.Patients determined to be inappropriate by physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Terauchi Yasuo |
Organization
Yokohama City University Hospital
Division name
Department of Endocrinology & Metabolism
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872800
goingderbygoingderby@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamada Masayo |
Organization
Yokohama Sakae Kyousai Hospital, Federation of National Public Service Personnel Mutual Associations
Division name
Department of Endocrinology & Metabolism
Zip code
Address
Katsura-chou 132, Sakae-ku, Yokohama, Kanagawa, Japan
TEL
045-891-2171
Homepage URL
Masayo-y@cameo.plala.or.jp
Sponsor or person
Institute
Yokohama City 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
国家公務員共済組合連合会横浜栄共済病院(神奈川県)
茅ヶ崎市立病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 20 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 19 | Day |
Last modified on
| 2014 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011798
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| Registered date | File name |
| Research case data | |
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