Unique ID issued by UMIN | UMIN000008286 |
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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 |
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
CERAMIQUE trial
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
CERAMIQUE trial
Japan |
Secondary osteoporosis
Endocrinology and Metabolism | Breast surgery |
Malignancy
NO
To clarify the efficacy and safety of risedronate plus eldecalcitol versus risedronate alone in a clinical setting.
Efficacy
Confirmatory
Pragmatic
Not applicable
Changes in bone mineral density (lumbar spine: DXA)
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Medicine |
risedronate (17.5mg/week)
risedronate (17.5 mg/week) + eldecalcitol (0.75 ug/day)
40 | years-old | <= |
100 | years-old | > |
Female
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.
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.
200
1st name | Yasuo |
Middle name | |
Last name | Imanishi |
Osaka City University Graduate School of Medicine
Department of Metabolism, Endocrinology and Molecular Medicine
545-8585
Asahi-machi 1-4-3, Abeno-ku, Osaka, 545-8585, Japan
06-6645-3806
imanishi@med.osaka-cu.ac.jp
1st name | Yasuo |
Middle name | |
Last name | Imanishi |
Osaka City University Graduate School of Medicine
Department of Metabolism, Endocrinology and Molecular Medicine
545-8585
Asahi-machi 1-4-3, Abeno-ku, Osaka, 545-8585, Japan
06-6645-3806
imanishi@med.osaka-cu.ac.jp
Osaka City University Graduate School of Medicine
None
Self funding
Osaka City University Ethical Committee
1-4-3, Asahi-machi, Abeno-ku, Osaka
66453457
ethics@med.osaka-cu.ac.jp
NO
大阪市立大学医学部附属病院(大阪府)
2012 | Year | 07 | Month | 01 | Day |
Not yet
Unpublished
Not yet
200
The increase in lumbar spine bone mineral density at 24 months was larger in comparison therapy group compared to monotherapy group.
2023 | Year | 05 | Month | 22 | Day |
All participants were postmenopausal women whose mean age was 66.30 years ols.
Combination therapy of eldecalcitol and risedronate with risedronate alone in an open-label randomized control trial
2 cases (hip fracture and clinical vertebral fracture) in a combination therapy group and 2 cases (clinical vertebral fracture and leg edema).
Changes in lumber spine bone mineral density
Completed
2012 | Year | 05 | Month | 01 | Day |
2023 | Year | 04 | Month | 05 | Day |
2012 | Year | 07 | Month | 01 | Day |
2019 | Year | 05 | Month | 01 | Day |
2012 | Year | 06 | Month | 28 | Day |
2023 | Year | 05 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009756
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