Viewing Study NCT04788290



Ignite Creation Date: 2024-05-06 @ 3:52 PM
Last Modification Date: 2024-10-26 @ 1:59 PM
Study NCT ID: NCT04788290
Status: COMPLETED
Last Update Posted: 2021-03-09
First Post: 2021-03-01

Brief Title: An Observational Study Assessing Effects in Patients With Combination Therapy With RaloxifeneCholecalciferol
Sponsor: Hanmi Pharmaceutical Company Limited
Organization: Hanmi Pharmaceutical Company Limited

Study Overview

Official Title: An Observational Study Assessing Effects on Quality of Life Medication Compliance Treatment Satisfaction in Patients With Combination Therapy With RaloxifeneCholecalciferol
Status: COMPLETED
Status Verified Date: 2021-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study examines quality of life and patient satisfaction in postmenopausal women receiving raloxifene to preventtreat osteoporosis and vitamin D to reduce risk of fracture using clinical practice data The purpose of this study is to observe quality of lifeQOL medication compliance and patient satisfaction who got combination therapy with raloxifenecholecalciferol raloxifene 60mg cholecalciferol 800 IU Rabone D Hanmi Pharma South Korea for 6 months
Detailed Description: Preventing bone loss is an important concern for women during post-menopausal period Menopause significantly speeds bone loss and increases the risk for osteoporosis This study was to investigate the effectiveness on quality of life QOL patient satisfaction in postmenopausal women receiving raloxifenecholecalciferol combination therapy In addition we analyzed adverse events to assess the safety profile of this drug

This study is a multicenter prospective non-critical observational study of women receiving raloxifenecholecalciferol raloxifene 60mg cholecalciferol 800 IU Rabone D Hanmi Pharma South Korea combination therapy to treat or prevent postmenopausal osteoporosis Data will be collected from patients receiving routine treatment at about 105 primary secondary or tertiary medical institutions in South Korea Each subject visits the institution according to the protocol that designed the follow-up visits for six months to examine changes in and factors influencing quality of life EQ-5D-5L method patient satisfaction with efficacy and convenience questionnaire and safety This study will approved by the institutions IRBs and is in compliance with clinical research ethics regulations

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None