NCT04788290

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,907

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

2.7 years

First QC Date

March 1, 2021

Last Update Submit

March 4, 2021

Conditions

Osteoporosis

Keywords

RaloxifeneCholecalciferolOsteoporosisQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Medication compliance (Rate of subjects taking more than 80% of the medication)

    6 months

  • Treatment satisfaction measured with questionnaire (Patient satisfaction)

    6 months

  • Evaluation of clinical laboratory changes (BTM(Bone turnover marker) CTX)

    6 months

  • Evaluation of clinical laboratory changes (BTM(Bone turnover marker) NTX)

    6 months

  • Evaluation of clinical laboratory changes (BTM(Bone turnover marker) BAP)

    6 months

  • +6 more secondary outcomes

Study Arms (1)

Single group(No interventional)

Other Name: Observational Rabone D®, Once daily administered per the locally approved product information

Other: Observational

Interventions

ObservationalOTHER

Rabone D®, Once daily administered per the locally approved product information

Single group(No interventional)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanmi Pharmaceutical Company Limited

Seoul, 05545, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Mi-Jeung KIM

    Hanmi Pharmaceutical Company Limited

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 9, 2021

Study Start

November 6, 2017

Primary Completion

July 13, 2020

Study Completion

July 13, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)