UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007398 |
|---|---|
| Receipt number | 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 16:05:14 |
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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
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
Sponsor or person
Institute
Gerontology Osaka City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008677
