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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05433207

Enrollment

1000

Registered

2022-06-27

Start date

2022-08-01

Completion date

2025-01-31

Last updated

2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Osteoporosis

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.

Interventions

DRUGEldecalcitol 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.)

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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
the severity of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)	through study completion, up to one year

Countries

China

Contacts

Primary ContactRitsu Ki

edrdimdisclosure@chugai-pharm.co.jponly use E-mail

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026