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

* 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

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 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


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

Value
https://center6.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