Clinical trial NCT04788290: An Observational Study Assessing Effects in Patients With Combination Therapy With Raloxifene/Cholecalciferol
Official title: An Observational Study Assessing Effects on Quality of Life, Medication Compliance, Treatment Satisfaction in Patients With Combination Therapy With Raloxifene/Cholecalciferol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: Raloxifene
Cholecalciferol
Osteoporosis
Quality of life
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2021-03-09
Enrollment: 3907
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The EuroQol EQ-5D
timeFrame: 6 months
Secondary outcomes:
measure: Medication compliance (Rate of subjects taking more than 80% of the medication)
timeFrame: 6 months
measure: Treatment satisfaction measured with questionnaire (Patient satisfaction)
timeFrame: 6 months
measure: Evaluation of clinical laboratory changes (BTM(Bone turnover marker) CTX)
timeFrame: 6 months
measure: Evaluation of clinical laboratory changes (BTM(Bone turnover marker) NTX)
timeFrame: 6 months
measure: Evaluation of clinical laboratory changes (BTM(Bone turnover marker) BAP)
timeFrame: 6 months
measure: Evaluation of clinical laboratory changes (BTM(Bone turnover marker) P1NP)
timeFrame: 6 months
measure: Evaluation of clinical laboratory changes (BTM(Bone turnover marker) osteocalcin)
timeFrame: 6 months
measure: Evaluation of clinical laboratory changes (25(OH)D level(25-hydroxyvitamin D level)
timeFrame: 6 months
measure: Reason for medication change
timeFrame: 6 months
measure: Evaluation of quality of life changes compared with prior medication regimens
timeFrame: 6 months
measure: Occurrence and aspect of adverse events(AEs)
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanmi Pharmaceutical Company Limited
Study officials:
affiliation: Hanmi Pharmaceutical Company Limited
name: Mi-Jeung KIM
role: STUDY_DIRECTOR
References: