UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004375
Receipt number R000005228
Scientific Title Study on preventive effect of risedronate administration on aromatase inhibitor-induced bone mineral loss in the endoclinical therapy for postmenopausal breast cancer patients
Date of disclosure of the study information 2010/11/15
Last modified on 2013/10/12 09:06:02

* 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

Study on preventive effect of risedronate administration on aromatase inhibitor-induced bone mineral loss in the endoclinical therapy for postmenopausal breast cancer patients

Acronym

Effect of risedronate on aromatase inhibitor-induced bone mineral loss in the postmenopausal breast cancer

Scientific Title

Study on preventive effect of risedronate administration on aromatase inhibitor-induced bone mineral loss in the endoclinical therapy for postmenopausal breast cancer patients

Scientific Title:Acronym

Effect of risedronate on aromatase inhibitor-induced bone mineral loss in the postmenopausal breast cancer

Region

Japan


Condition

Condition

Hormone-receptor positive, postmenopausal primary breast cancer

Classification by specialty

Endocrinology and Metabolism Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Assessing preventive effect of risedronate administration on aromatase inhibitor-induced bone mineral loss in the postmenopausal breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

change from baseline on 18 month in bone mineral density

Key secondary outcomes

change from baseline on 18 month in bone turnover markers


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

An aromatase inhibitor, such as Anasrozole, Letrozole or Exemestane

Interventions/Control_2

An aromatase inhibitor + Risedronate, 17.5mg, orally, once a week

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1)primary breast cancer (T1-2N0M0)
2)Post menopausal
3)ER+ve
4)HER2-ve
5)consitable eligible to aromatase inhibitors, i.e. ANA, LET and EXE
6) WBC>=3500 and <12,000, Hb>=9.0, PLT >=100,000, T-Bil <=2.0, AST, ALT<=100,CCR >=50ml/min, ECG normal
7) PS 0-1
8)Signed written informed consent

Key exclusion criteria

1) Inflamatory breast cancer
2) Hypersensitivity to any reagents used in this trial.
3) Serious complications
4) Excess alcohol consumption
5) Habitual smoker
6) Family history of hip joint fracture
7) Active dental and/ or periodontal disease which requires treatment
8) Withdrawal of informed concent
9) Patients who are judged inappropriate for the clinical trial by doctors

Target sample size

64


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masakazu Toi

Organization

Graduate School of Medicine Kyoto University

Division name

Breast Surgery

Zip code


Address

54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan

TEL

075-751-3660

Email

toi@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoharu Sugie

Organization

Graduate School of Medicine Kyoto University

Division name

Breast Surgery

Zip code


Address

54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan

TEL

075-751-3660

Homepage URL


Email

sugie@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Graduate School of Medicine Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

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

京都大学病院


Other administrative information

Date of disclosure of the study information

2010 Year 11 Month 15 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

Terminated

Date of protocol fixation

2010 Year 09 Month 27 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 10 Month 12 Day

Last modified on

2013 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005228


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name