SBP-15

Phase 2

Recruiting

• Conditions: ER positive early breast cancer; aromatase inhibitors induced osteoporosis

• Registration Number: JPRN-jRCT1061210010
• Lead Sponsor: Tadahiko Shien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

ER positive postmenopausal breast cancer patients
Patients recieving AI (<2 yerars)
Patients diagnosed osteoporosis
Patients without treatment of osteoporosis
CCr>35mL/min
Serum Ca>8.0 mg/dL
Without dental treatment
With informed consent

Exclusion Criteria

Metastatic breast cancer patients
Allargy with bisphosphonate
Renal disfunction
Active other cancers
Treated with bisphosphonate
The medical doctor judged ineligible

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3 years rate of bone density change

Secondary Outcome Measures

Name	Time	Method
5 years rate of bone metastasis<br>5 years rate of desiese free survival<br>Safety<br>Rate of fructure of vertebral bone<br>Rate of fructutre of non-vertrbral bone