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NCT Number: NCT04788290

An Observational Study Assessing Effects 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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Hanmi Pharmaceutical Company Limited

Seoul, 05545, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

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

Primary outcomes

  1. The EuroQol EQ-5D

    Time frame: 6 months

    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).

Secondary outcomes

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

    Time frame: 6 months

    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.

  2. Treatment satisfaction measured with questionnaire (Patient satisfaction)

    Time frame: 6 months

    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).

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

    Time frame: 6 months

    The following laboratory test is performed at each visit.

    : CTX (lab unit: e.g. ng/L)

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

    Time frame: 6 months

    The following laboratory test is performed at each visit.

    : NTX (lab unit: e.g. nM BCE/mM creatinine)

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

    Time frame: 6 months

    The following laboratory test is performed at each visit.

    : BAP (lab unit: e.g. mcg/L)

  6. Evaluation of clinical laboratory changes (BTM(Bone turnover marker) P1NP)

    Time frame: 6 months

    The following laboratory test is performed at each visit.

    : P1NP (lab unit: e.g. μg/L)

  7. Evaluation of clinical laboratory changes (BTM(Bone turnover marker) osteocalcin)

    Time frame: 6 months

    The following laboratory test is performed at each visit.

    : osteocalcin (lab unit: e.g. ng/mL)

  8. Evaluation of clinical laboratory changes (25(OH)D level(25-hydroxyvitamin D level)

    Time frame: 6 months

    The following laboratory test is performed at each visit.

    : 25(OH)D level(25-hydroxyvitamin D level) (lab unit: e.g. ng/mL)

  9. Reason for medication change

    Time frame: 6 months

    Reason for medication(prior-medication to prevent/treat osteoporosis and concomitant medications) change is collected at each visit.

  10. Evaluation of quality of life changes compared with prior medication regimens

    Time frame: 6 months

    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.

  11. Occurrence and aspect of adverse events(AEs)

    Time frame: 6 months

    After receiving Rabone D®, new adverse events and detailed information are collected at visit 2 and visit 3.

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2021
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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