SBP-15

JRCT ID: jRCT1061210010

Registered date:07/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ER positive early breast cancer
• Date of first enrollment: 07/07/2021
• Target sample size: 200
• Study type: Interventional

Intervention(s)

Treatment of AI induced osteoporosis by Bisphosphonate
(Zoledronic acid hydrate 5mg/year div. >15min)

Outcome(s)

• Primary Outcome: 3 years rate of bone density change

Secondary Outcome

5 years rate of bone metastasis
5 years rate of desiese free survival
Safety
Rate of fructure of vertebral bone
Rate of fructutre of non-vertrbral bone

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

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

Related Information

• Primary Sponsor: Tadahiko Shien