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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008286

Enrollment

200

Registered

2012-07-01

Start date

2012-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary osteoporosis

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Changes in bone mineral density (lumbar spine: DXA)	—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactYasuo Imanishi

Osaka City University Graduate School of Medicine Department of Metabolism, Endocrinology and Molecular Medicine

imanishi@med.osaka-cu.ac.jp06-6645-3806

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026