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

Not yet recruiting

• Conditions: Postmenopausal Osteoporosis

• Registration Number: NCT05433207
• Lead Sponsor: Chugai Pharmaceutical

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-21
• Last Update Submitted: 2022-06-21
• Study First Posted: 2022-06-27
• Last Update Posted: 2022-06-27
• Study Start: 2022-08-01
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China