UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008286
Receipt number R000009756
Scientific Title Combination therapy of Eldecalcitol with Risedronate on Aromatase inhibitor treated post-operative Mammary carcinoma In the prevention of bone QUality and quantity Exacerbation (CERAMIQUE) randomized trial
Date of disclosure of the study information 2012/07/01
Last modified on 2023/05/22 20:45:48

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Basic information

Public title

Combination therapy of Eldecalcitol with Risedronate on Aromatase inhibitor treated post-operative Mammary carcinoma In the prevention of bone QUality and quantity Exacerbation (CERAMIQUE) randomized trial

Acronym

CERAMIQUE trial

Scientific Title

Combination therapy of Eldecalcitol with Risedronate on Aromatase inhibitor treated post-operative Mammary carcinoma In the prevention of bone QUality and quantity Exacerbation (CERAMIQUE) randomized trial

Scientific Title:Acronym

CERAMIQUE trial

Region

Japan


Condition

Condition

Secondary osteoporosis

Classification by specialty

Endocrinology and Metabolism Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the efficacy and safety of risedronate plus eldecalcitol versus risedronate alone in a clinical setting.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes in bone mineral density (lumbar spine: DXA)

Key secondary outcomes

Changes in bone mineral density (total hip: DXA, antebrachial bone: QUS).
Incidence of fractures (vertebral fractures, non- vertebral fractures).
Changes in bone metabolic markers.
Safety.
QOL.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

risedronate (17.5mg/week)

Interventions/Control_2

risedronate (17.5 mg/week) + eldecalcitol (0.75 ug/day)

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

40 years-old <=

Age-upper limit

100 years-old >

Gender

Female

Key inclusion criteria

1. Post-operative mammary carcinoma patients whose TNM stage from 0 to IIIA and under receiving aromatase inhibitor.
2. Patients who are 40 years or older, with more than 2 years after menopause.
3. Patients who received risedronate 17.5 mg/week more than 12 months and can be observed for 2 years.
4. Patients with less than -1.0 T score of lumber or total femoral BMD, or with fragile vertebral fractures.
5. Patients acquired informed consent about this study.

Key exclusion criteria

1. Contraindication for risedronate use.
2. Patients medicated with warfarin.
3. Using other osteoporosis drugs such as active vitamin D3, selective estrogen receptor modulators (SERMs), ipriflavone, calcitonin, and bisphosphonate except risedronate.
4. Patients suffered from malignancies except mammary carcinoma.
5. Patients with serious infection or under serious condition such as malnutrition.
6. Patients under insulin therapy.
7. Patients with tendency to fall due to paroxysmal disorders.
8. Patients who are unable to acquire informed consent due to neuropsychiatric illnesses or brain diseases such as dementia.
9. Patients with breast feeding, pregnancy, or possible pregnancy.
10. Patients whose corrected serum calcium levels are more than 10.4 mg/dl at the enrollment to this trial.
11. Patients whose corrected urinary calcium levels are more than 0.3 Ca (mg)/Cre (mg) at the enrollment to this trial.
12. Patients who are advised to remove their teeth at the enrollment to this trial.
13. Patients with past histories of osteonecrosis of the jaws.
14. Patients judged inappropriate by attending physicians.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yasuo
Middle name
Last name Imanishi

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Metabolism, Endocrinology and Molecular Medicine

Zip code

545-8585

Address

Asahi-machi 1-4-3, Abeno-ku, Osaka, 545-8585, Japan

TEL

06-6645-3806

Email

imanishi@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Yasuo
Middle name
Last name Imanishi

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Metabolism, Endocrinology and Molecular Medicine

Zip code

545-8585

Address

Asahi-machi 1-4-3, Abeno-ku, Osaka, 545-8585, Japan

TEL

06-6645-3806

Homepage URL


Email

imanishi@med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name



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

Osaka City University Ethical Committee

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka

Tel

66453457

Email

ethics@med.osaka-cu.ac.jp


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

大阪市立大学医学部附属病院(大阪府)


Other administrative information

Date of disclosure of the study information

2012 Year 07 Month 01 Day


Related information

URL releasing protocol

Not yet

Publication of results

Unpublished


Result

URL related to results and publications

Not yet

Number of participants that the trial has enrolled

200

Results

The increase in lumbar spine bone mineral density at 24 months was larger in comparison therapy group compared to monotherapy group.

Results date posted

2023 Year 05 Month 22 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

All participants were postmenopausal women whose mean age was 66.30 years ols.

Participant flow

Combination therapy of eldecalcitol and risedronate with risedronate alone in an open-label randomized control trial

Adverse events

2 cases (hip fracture and clinical vertebral fracture) in a combination therapy group and 2 cases (clinical vertebral fracture and leg edema).

Outcome measures

Changes in lumber spine bone mineral density

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 05 Month 01 Day

Date of IRB

2023 Year 04 Month 05 Day

Anticipated trial start date

2012 Year 07 Month 01 Day

Last follow-up date

2019 Year 05 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 06 Month 28 Day

Last modified on

2023 Year 05 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009756


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name