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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007398
Receipt No. R000008677
Scientific Title Effect of Bazedoxifene to osteoporotic patients under active vitamin D treatment
Date of disclosure of the study information 2012/02/28
Last modified on 2012/02/28

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Basic information
Public title Effect of Bazedoxifene to osteoporotic patients under active vitamin D treatment
Acronym Effect of Bazedoxifene to osteoporotic patients under active vitamin D treatment
Scientific Title Effect of Bazedoxifene to osteoporotic patients under active vitamin D treatment
Scientific Title:Acronym Effect of Bazedoxifene to osteoporotic patients under active vitamin D treatment
Region
Japan

Condition
Condition osteoporosis
Classification by specialty
Medicine in general Endocrinology and Metabolism Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the effect of the combination of Bazedoxifene in osteoporotic patients undergoing treatment with active vitamin D through the change in the serum TRACP-5b level.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Reduction of TRACP-5b after Bazedoxifene treatment at 6 months compared with other markers.
Key secondary outcomes TRACP-5b change at 6th month after Bazedoxifene discontinuation
Changes of lumbar BMD and femoral neck BMD form baseline
Changes of the other bone markers from baseline
Changes of lipid profiles from baseline

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 Single-arm study with first12 months treated with Bazedoxifene 20mg/day and vitamin D 0.0005-0.001mg/day and further 6 months treated with vitamin D only
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patients with postmenopausal osteoporosis, or patients with high risk of fracture as defined by the guideline (Japanese guidelines for the prevention and treatment of osteoporosis 2006 edition) that are undergoing treatment with active vitamin D(Alfacalcidol 0.0005-0.001mg/day) for at least 6 months
Key exclusion criteria (1) Patients treated with bisphosphonates over 2 weeks within the previous 12 months;
(2) Patients that had been treated with medications that may affect bone metabolism within the previous 3 months with exception to calcium and vitamin D;
(3) Patients with allergic reaction to SERM or contraindication to SERM;
(4) Patients with kidney dysfunction (serum creatinine >1.6mg/dl);
(5) Acute phase of fracture;
(6) Immobility
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takami Miki
Organization Osaka City University
Division name Gerontology
Zip code
Address 1-4-3 Asahi-machi Osakashiabeno-ku, Osaka-hu
TEL 06-6645-3889
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Masaki
Organization Osaka City University
Division name Gerontology
Zip code
Address
TEL 06-6645-3889
Homepage URL
Email

Sponsor
Institute Gerontology Osaka City University
Institute
Department

Funding Source
Organization Pfizer Japan Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kousai-in Municipal Hospital
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 大阪市立大学附属病院

Other administrative information
Date of disclosure of the study information
2012 Year 02 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 Enrolling by invitation
Date of protocol fixation
2011 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
2014 Year 12 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 28 Day
Last modified on
2012 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008677

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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