OsteoporosisNCT04788290
An Observational Study Assessing Effects in Patients With Combination Therapy With Raloxifene/Cholecalciferol
An observational study of Osteoporosis, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Observational
- How many people
- 3,907 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Nov 2017to 13 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients for whom use of raloxifene/cholecalciferol combination therapy is prohibited
- Pregnant women, nursing women or child-bearing aged females deemed capable of pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Observational
- Keywords
- Raloxifene, Cholecalciferol, Osteoporosis, Quality of life
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Rabone D®, Once daily administered per the locally approved product information
| Study group | Role | What they receive |
|---|---|---|
| Single group(No interventional) | Other Name: Observational Rabone D®, Once daily administered per the locally approved product information Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (11)
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.
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 months
Reason for medication change
Reason for medication(prior-medication to prevent/treat osteoporosis and concomitant medications) change is collected at each visit.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start6 Nov 2017
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,907 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mi-Jeung KIM, Study director, Hanmi Pharmaceutical Company Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788290
- Sponsor's protocol ID
- HM-RAB-OS-01
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Assessing Effects on Quality of Life, Medication Compliance, Treatment Satisfaction in Patients With Combination Therapy With Raloxifene/Cholecalciferol
- ClinicalTrials.gov ID
- NCT04788290
- Acronym / sponsor ID
- HM-RAB-OS-01
- Conditions
- Osteoporosis
- Keywords
- Raloxifene, Cholecalciferol, Osteoporosis, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,907 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group(No interventional) | – | Other: ObservationalOther Name: Observational Rabone D®, Once daily administered per the locally approved product information |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients for whom use of raloxifene/cholecalciferol combination therapy is prohibited
- Pregnant women, nursing women or child-bearing aged females deemed capable of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalRabone D®, Once daily administered per the locally approved product information | Other | Single group(No interventional) |
Primary outcome
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).
11 secondary outcomes
Medication compliance (Rate of subjects taking more than 80% of the medication)
Time frame: 6 months
Treatment satisfaction measured with questionnaire (Patient satisfaction)
Time frame: 6 months
Evaluation of clinical laboratory changes (BTM(Bone turnover marker) CTX)
Time frame: 6 months
Evaluation of clinical laboratory changes (BTM(Bone turnover marker) NTX)
Time frame: 6 months
Evaluation of clinical laboratory changes (BTM(Bone turnover marker) BAP)
Time frame: 6 months
Evaluation of clinical laboratory changes (BTM(Bone turnover marker) P1NP)
Time frame: 6 months
Evaluation of clinical laboratory changes (BTM(Bone turnover marker) osteocalcin)
Time frame: 6 months
Evaluation of clinical laboratory changes (25(OH)D level(25-hydroxyvitamin D level)
Time frame: 6 months
Reason for medication change
Time frame: 6 months
Evaluation of quality of life changes compared with prior medication regimens
Time frame: 6 months
Occurrence and aspect of adverse events(AEs)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mi-Jeung KIM study director
Hanmi Pharmaceutical Company Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The EuroQol EQ-5D (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.