NCT05433207

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
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.)

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2022-06-27
• Last updated: 2022-06-27

Locations

1 site across 1 country: China