CERAMIQUE trial

JRCT ID: jRCTs051180179

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: secondary osteoporosis
• Date of first enrollment: 09/10/2012
• Target sample size: 200
• Study type: Interventional

Intervention(s)

Control arm: risedronate (17.5 mg/week)
Interventional arm: risedronate (17.5 mg/week) + eldecalcitol (0.75 micro g/day)

Outcome(s)

• Primary Outcome: Changes in bone mineral density (lumbar spine: DXA)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Imanishi Yasuo
• Source(s) of Monetary Support: CHUGAI PHARMACEUTICAL CO., LTD.
• Secondary ID(s): UMIN000008286