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

Chugai Pharmaceutical1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Postmenopausal Osteoporosis

Interventions

Eldecalcitol soft capsulesDRUG

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.)

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

Outcomes

Primary Outcomes

the rates of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake

Time frame: one year from Edirol dosing date

the odds ratios of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake

Time frame: one year from Edirol dosing date

the proportion of each type of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)

Time frame: through study completion, up to one year

the incidence of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)

Time frame: through study completion, up to one year

the severity of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)

Time frame: through study completion, up to one year

Central Contacts

Ritsu Ki

CONTACT

only use E-mail edrdimdisclosure@chugai-pharm.co.jp

Data from ClinicalTrials.gov

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