An Observational Study Assessing Effects in Patients With Combination Therapy With Raloxifene/Cholecalciferol

An Observational Study Assessing Effects on Quality of Life, Medication Compliance, Treatment Satisfaction in Patients With Combination Therapy With Raloxifene/Cholecalciferol

This study examines quality of life and patient satisfaction in postmenopausal women receiving raloxifene to prevent/treat osteoporosis, and vitamin D to reduce risk of fracture using clinical practice data. The purpose of this study is to observe quality of life(QOL), medication compliance and patient satisfaction who got combination therapy with raloxifene/cholecalciferol (raloxifene 60mg + cholecalciferol 800 IU, Rabone D®, Hanmi Pharma, South Korea) for 6 months.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Other: Observational

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 raloxifene/cholecalciferol 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 raloxifene/cholecalciferol (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 Type: Observational
• Enrollment (Actual): 3907

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05545
    • Hanmi Pharmaceutical Company Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women are at elevated risk of rapid onset osteoporosis, suggesting broad merit in prevention and treatment strategies. This study examines quality of life and patient satisfaction in postmenopausal women receiving raloxifene to prevent/treat osteoporosis, and vitamin D to reduce risk of fracture using clinical practice data.

Description

Inclusion Criteria:

• Postmenopausal women who need to prevent/treat osteoporosis
• Subject who got raloxifene/cholecalciferol combination therapy prescription with confirmation by the investigator's medical decision
• Subjects who can consent voluntarily

Exclusion Criteria:

• Patients for whom use of raloxifene/cholecalciferol combination therapy is prohibited
• Pregnant women, nursing women or child-bearing aged females deemed capable of pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single group(No interventional); Other Name: Observational Rabone D®, Once daily administered per the locally approved product information	Other: Observational; Rabone D®, Once daily administered per the locally approved product information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The EuroQol EQ-5D	Change and impact factor of quality of life measured with the EuroQol (EQ-5D) EQ-5D-5L is designed to measure health conditions and it consists of 5 questions relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Measuring EQ-5D is performed at each visit. The EQ-5D-5L consists of descriptive system with 5 dimensions. Each dimension has 5 levels: No problems(1), Slight problems(2), Moderate problems(3), Severe problems(4), and Extreme problems(5).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication compliance (Rate of subjects taking more than 80% of the medication)	This study is to learn more about the relationship between quality of life, patient satisfaction and medication compliance. Measuring medication compliance is performed at each visit. The subjects taking more than 80% are defined as compliance group, and the subjects taking less than 80% are defined as non-compliance group. Medication compliance will be compared between compliance group and non-compliance group.	6 months
Treatment satisfaction measured with questionnaire (Patient satisfaction)	This study is to learn more about the relationship between quality of life, patient satisfaction and medication compliance. Measuring patient satisfaction is performed at each visit. Treatment satisfaction is measured with 5 satisfaction degrees(Extremely satisfied, Satisfied, Moderate, Dissatisfied, and Extremely dissatisfied).	6 months
Evaluation of clinical laboratory changes (BTM(Bone turnover marker) CTX)	The following laboratory test is performed at each visit. : CTX (lab unit: e.g. ng/L)	6 months
Evaluation of clinical laboratory changes (BTM(Bone turnover marker) NTX)	The following laboratory test is performed at each visit. : NTX (lab unit: e.g. nM BCE/mM creatinine)	6 months
Evaluation of clinical laboratory changes (BTM(Bone turnover marker) BAP)	The following laboratory test is performed at each visit. : BAP (lab unit: e.g. mcg/L)	6 months
Evaluation of clinical laboratory changes (BTM(Bone turnover marker) P1NP)	The following laboratory test is performed at each visit. : P1NP (lab unit: e.g. μg/L)	6 months
Evaluation of clinical laboratory changes (BTM(Bone turnover marker) osteocalcin)	The following laboratory test is performed at each visit. : osteocalcin (lab unit: e.g. ng/mL)	6 months
Evaluation of clinical laboratory changes (25(OH)D level(25-hydroxyvitamin D level)	The following laboratory test is performed at each visit. : 25(OH)D level(25-hydroxyvitamin D level) (lab unit: e.g. ng/mL)	6 months
Reason for medication change	Reason for medication(prior-medication to prevent/treat osteoporosis and concomitant medications) change is collected at each visit.	6 months
Evaluation of quality of life changes compared with prior medication regimens	This study is to learn more about quality of life changes compared with prior medication regimens. At visit 1, all subjects conduct questionnaire surveys about quality of life. If there are subjects having prior medication regimens for osteoporosis treatment/prevention, these regimens are classified by medication group to compare and evaluate the change in quality of life after taking combination therapy with raloxifene/cholecalciferol. The prior medications are standardized according to ATC(Anatomical Therapeutic Chemical) classification and analyzed based on level 4 and level 5. Change of EQ-5D index according to prior medication regimens is analyzed with average difference of the sum value.	6 months
Occurrence and aspect of adverse events(AEs)	After receiving Rabone D®, new adverse events and detailed information are collected at visit 2 and visit 3.	6 months

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 6, 2017
• Primary Completion (ACTUAL): July 13, 2020
• Study Completion (ACTUAL): July 13, 2020

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (ACTUAL): March 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Osteoporosis; Cholecalciferol; Raloxifene
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: HM-RAB-OS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No