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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05433207
Other study ID # EDR2201CN
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date January 31, 2025

Study information

Verified date June 2022
Source Chugai Pharmaceutical
Contact Ritsu Ki
Phone only use E-mail
Email edrdimdisclosure@chugai-pharm.co.jp
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date January 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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: - Exclude if any of the following: - Men - No osteoporosis - Other osteoporosis (not postmenopausal) - Started Edirol before ICF signature - Did not sign ICF

Study Design


Intervention

Drug:
Eldecalcitol soft capsules
0.75 µg orally once a day during the intensive monitoring period. (The dose can be appropriately reduced to 0.5 µg according to symptoms, once a day.)

Locations

Country Name City State
China Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the rates of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake one year from Edirol dosing date
Primary the odds ratios of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake one year from Edirol dosing date
Primary the proportion of each type of adverse drug reactions (including hypercalcemia, urolithiasis, etc.) through study completion, up to one year
Primary the incidence of adverse drug reactions (including hypercalcemia, urolithiasis, etc.) through study completion, up to one year
Primary the severity of adverse drug reactions (including hypercalcemia, urolithiasis, etc.) through study completion, up to one year
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