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

Chugai Pharmaceutical

Status: Not yet enrolling

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Eldecalcitol soft capsules

Study type: Observational

Funder types: Industry

Identifiers

NCT05433207

EDR2201CN

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: Female

Volunteers: No 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