Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis
About the study
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 without calcium intake (including dietary supplements, excepting calcium from meals), and to monitor the type, incidence, severity, and relevance of other adverse drug reactions,including urolithiasis.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
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 CRITERIA
Exclusion Criteria:
Exclude if any of the following:
- Men
- No osteoporosis
- Other osteoporosis (not postmenopausal)
- Started Edirol before ICF signature
- Did not sign ICF
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Postmenopausal Osteoporosis
Participants needed
1000
Est. Completion Date
Jan 31, 2025
Treatment type
Observational
Sponsor
Chugai Pharmaceutical
ClinicalTrials.gov identifier
NCT05433207
Study number
EDR2201CN
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