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

• Sponsor: Chugai Pharmaceutical (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05433207
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 33.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Osteoporosis	Drug: Eldecalcitol soft capsules

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: EDIROL Drug Intensive Monitoring: Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Jan 31, 2025
• Anticipated Study Completion Date: Jan 31, 2025

Outcome Measures

Primary Outcome Measures

1. the rates of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake [one year from Edirol dosing date]

2. the odds ratios of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake [one year from Edirol dosing date]

3. the proportion of each type of adverse drug reactions (including hypercalcemia, urolithiasis, etc.) [through study completion, up to one year]

4. the incidence of adverse drug reactions (including hypercalcemia, urolithiasis, etc.) [through study completion, up to one year]

5. the severity of adverse drug reactions (including hypercalcemia, urolithiasis, etc.) [through study completion, up to one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing		China	100730

Sponsors and Collaborators

• Chugai Pharmaceutical

Investigators

• Principal Investigator: Weibo Xia, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chugai Pharmaceutical
• ClinicalTrials.gov Identifier: NCT05433207
• Other Study ID Numbers: EDR2201CN
• First Posted: Jun 27, 2022
• Last Update Posted: Jun 27, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Eldecalcitol

Study Results

No Results Posted as of Jun 27, 2022