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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008286
Receipt No. 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 2016/12/31

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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
Middle name
Last name Yasuo Imanishi, M.D., Ph.D.
Organization Osaka City University Graduate School of Medicine
Division name Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
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
Middle name
Last name Yasuo Imanishi, M.D., Ph.D.
Organization Osaka City University Graduate School of Medicine
Division name Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
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
Institute Osaka City University Graduate School of Medicine
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2012 Year 05 Month 01 Day
Date of IRB
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
2016 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.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


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