Status:
UNKNOWN
Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
Brief Summary
This is a post-marketing drug intensive monitoring surveillance with an observational, non-interventional design. The objectives are to compare the incidence of hypercalcemia in patients with and with...
Eligibility Criteria
Inclusion
- Postmenopausal osteoporosis patients who signed the informed consent form and are expected to receive Edirol during the intensive monitoring period.
- Patients with postmenopausal osteoporosis
- Patients who signed the informed consent form
- Patients who are expected to receive Edirol during planned enrollment period
Exclusion
- Exclude if any of the following:
- Men
- No osteoporosis
- Other osteoporosis (not postmenopausal)
- Started Edirol before ICF signature
- Did not sign ICF
Key Trial Info
Start Date :
August 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05433207
Start Date
August 1 2022
End Date
January 31 2025
Last Update
June 27 2022
Active Locations (1)
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1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100730