Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis

Postmenopausal Osteoporosis Clinical Trial

Official title:

EDIROL Drug Intensive Monitoring: Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05433207
• Other study ID #: EDR2201CN
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

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