UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010074
Receipt No. 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

* 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 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
Email 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
Email Masayo-y@cameo.plala.or.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011798

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.