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

Not Applicable

• Conditions: Secondary osteoporosis

• Registration Number: JPRN-UMIN000008286
• Lead Sponsor: Osaka City University Graduate School of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-01
• Study Completion: 2019-05-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in bone mineral density (lumbar spine: DXA)

Secondary Outcome Measures

Name	Time	Method
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.