OsteoporosisPhase 4NCT05387200
Phase IV Clinical Trial to Evaluate Efficacy and Safety of MASI BONE S (Alendronate Sodium Trihydrate) in Postmenopausal Women With Osteoporosis
A Phase 4 study testing Masibone S and Fosamax in people with Osteoporosis, run by Yonsei University at 1 site in South Korea.
Trial summary
This study aims to prove non-inferiority of the efficacy of Masibone S (alendronate sodium trihydrate 70mg, oral solution) on the treatment of postmenopausal osteoporosis compared to the efficacy of Fosamax (alendronate sodium 70mg, oral tablet). Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Masibone S and Fosamax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jul 2021to May 2023
- Phase
- Phase 4
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postmenopausal women ≥50 years old
- osteoporosis - BMD T-score ≤-2.5 at lumbar spine, femoral neck, or total hip within previous 24 weeks
- BMD T-score -1.0~-2.5 at lumbar spine, femoral neck, or total hip within previous 24 weeks and history of osteoporotic fractures - BMD T-score -1.0~-2.5 at lumbar spine, femoral neck, or total hip within previous 24 weeks and FRAX MOF >20% or HF >3%
- Those who voluntarily agree in written form to participate in the clinical trial after hearing the explanation of this clinical trial and those who do not have any of exclusion criteria
Who cannot join
- Patient with history of drugs that affect bone mineral density - bisphosphonate, denosumab, teriparatide, romosozumab within one year - calcitonin or analogues, calcimimetics within previous 12 weeks - strontium or fluoride for treating osteoporosis at any time in the past
- Patients with history of osteonecrosis of jaw, osteonecrosis of external ear canal, or atypical femoral fracture
- Patients with history of invasive dental procedure (tooth extraction, implant, oral surgery etc) within previous 24 weeks or patients who plan for invasive dental procedure during the clinical trial period
- Patients with risk of aspiration (esophageal disorders such as esophageal stricture, achalasia or patients who can not sit or stand for more than 30 minutes)
- Patients with severe renal dysfunction (eGFR by MDRD <30 ml/min/1.73m2 or on dialysis) or liver dysfunction (AST or ALT ≥x3 upper limit of normal reference range)
- Patients who are under treatment or plan for treatment due to solid tumor or hematologic malignancy
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- Patients with secondary osteoporosis (persistent systemic steroid use, uncontrolled hyperthyroidism, primary hyperparathyroidism)
- Hypocalcemia (albumin-corrected calcium <2.1mmol/L) or vitamin D deficiency (25OHD <10ng/mL) during screening
- Patients with known allergic reaction, hypersensitivity, or intolerance to bisphosphonate and other components of intervention drugs during screening (including latex allergy and hereditary fructose intolerance)
- Patients who the examiner considers not eligible for clinical trials
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Yumie Rhee, +82-2-2228-0883, yumie@yuhs.ac
About this study
Official title: A Multi Center, Randomized, Open-label, Parallel, Phase IV Clinical Trial to Evaluate Efficacy and Safety of MASI BONE S (Alendronate Sodium Trihydrate) in Postmenopausal Women With Osteoporosis
This study aims to prove non-inferiority of the efficacy of Masibone S (alendronate sodium trihydrate 70mg, oral solution) on the treatment of postmenopausal osteoporosis compared to the efficacy of Fosamax (alendronate sodium 70mg, oral tablet). The effect of Masibone S and Fosamax on bone mineral density in postmenopausal women with osteoporosis will be compared and analyzed. This study included a total 170 patients (85 per subgroup) for multi-center, randomized, open-label, parallel clinical trial. The drugs will be maintained for a total of 48 weeks. The primary endpoint is the difference of bone mineral density change at lumbar spine measured by DEXA between two groups.
- Conditions
- Osteoporosis
- Being tested
- Masibone S, Fosamax
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masibone SDrug
The investigators will evaluate the change of bone mineral density at lumbar spine measured by DEXA after 48 weeks of alendronate sodium trihydrate 70mg (oral solution) 1 bottle weekly and cholecalciferol 1000U/calcium 100mg 1T daily use.
FosamaxDrug
The investigators will evaluate the change of bone mineral density at lumbar spine measured by DEXA after 48 weeks of alendronate sodium 70mg (oral tablet) 1T weekly and cholecalciferol 1000U/calcium 100mg 1T daily use.
| Study group | Role | What they receive |
|---|---|---|
| Masibone S | Experimental | Masibone S (alendronate sodium trihydrate 70mg, oral solution) 1 bottle weekly and cholecalciferol 1000U/calcium 100mg 1T daily for 48 weeks Receives: Drug: Masibone S |
| Fosamax | Active comparator | Fosamax (aledronate sodium 70mg, oral tablet) 1T weekly and cholecalciferol 1000U/calcium 100mg 1T daily for 48 weeks Receives: Drug: Fosamax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of bone mineral density at lumbar spine
DEXA is used to evaluate the change of bone mineral density at lumbar spine after 48 weeks of drug intervention compared to those at baseline
Measured: 48 weeks
Secondary outcomes (2)
Change of serum levels of bone turnover markers
Serum levels bone turnover markers (CTX and P1NP) is measured at baseline and after 24 and 48 weeks of drug intervention and the change of serum levels of CTX and P1NP is evaluated.
Measured: 24 and 48 weeks
Adherence to drug
The proportion of patients who compliantly uses drugs after 24 and 48 weeks of intervention will be evaluated.
Measured: 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start2 Jul 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yumie Rhee, Principal investigator, Department of Internal Medicine, Endocrine Research Institute, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387200
- Sponsor's protocol ID
- 4-2021-0486
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baek S, Ahn SH, Hong N, Seo DH, Hong S, Rhee Y. Efficacy and safety of weekly liquid alendronate in Korean postmenopausal women with osteoporosis: a 12-month, multi-center, randomized trial. Arch Osteoporos. 2024 Nov 26;19(1):119. doi: 10.1007/s11657-024-01480-6.
PubMed 39589664
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center, Randomized, Open-label, Parallel, Phase IV Clinical Trial to Evaluate Efficacy and Safety of MASI BONE S (Alendronate Sodium Trihydrate) in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT05387200
- Acronym / sponsor ID
- 4-2021-0486
- Conditions
- Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 24 May 2022 (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 aims to prove non-inferiority of the efficacy of Masibone S (alendronate sodium trihydrate 70mg, oral solution) on the treatment of postmenopausal osteoporosis compared to the efficacy of Fosamax (alendronate sodium 70mg, oral tablet). The effect of Masibone S and Fosamax on bone mineral density in postmenopausal women with osteoporosis will be compared and analyzed. This study included a total 170 patients (85 per subgroup) for multi-center, randomized, open-label, parallel clinical trial. The drugs will be maintained for a total of 48 weeks. The primary endpoint is the difference of bone mineral density change at lumbar spine measured by DEXA between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Masibone S | Experimental | Drug: Masibone SMasibone S (alendronate sodium trihydrate 70mg, oral solution) 1 bottle weekly and cholecalciferol 1000U/calcium 100mg 1T daily for 48 weeks |
| Fosamax | Active comparator | Drug: FosamaxFosamax (aledronate sodium 70mg, oral tablet) 1T weekly and cholecalciferol 1000U/calcium 100mg 1T daily for 48 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- postmenopausal women ≥50 years old
- osteoporosis - BMD T-score ≤-2.5 at lumbar spine, femoral neck, or total hip within previous 24 weeks
- Those who voluntarily agree in written form to participate in the clinical trial after hearing the explanation of this clinical trial and those who do not have any of exclusion criteria
Key exclusion criteria (10 listed)
- Patient with history of drugs that affect bone mineral density - bisphosphonate, denosumab, teriparatide, romosozumab within one year - calcitonin or analogues, calcimimetics within previous 12 weeks - strontium or fluoride for treating osteoporosis at any time in the past
- Patients with history of osteonecrosis of jaw, osteonecrosis of external ear canal, or atypical femoral fracture
- Patients with history of invasive dental procedure (tooth extraction, implant, oral surgery etc) within previous 24 weeks or patients who plan for invasive dental procedure during the clinical trial period
- Patients with risk of aspiration (esophageal disorders such as esophageal stricture, achalasia or patients who can not sit or stand for more than 30 minutes)
- Patients with severe renal dysfunction (eGFR by MDRD <30 ml/min/1.73m2 or on dialysis) or liver dysfunction (AST or ALT ≥x3 upper limit of normal reference range)
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 |
|---|---|---|
| Masibone SThe investigators will evaluate the change of bone mineral density at lumbar spine measured by DEXA after 48 weeks of alendronate sodium trihydrate 70mg (oral solution) 1 bottle weekly and cholecalciferol 1000U/calcium 100mg 1T daily use. | Drug | Masibone S |
| FosamaxThe investigators will evaluate the change of bone mineral density at lumbar spine measured by DEXA after 48 weeks of alendronate sodium 70mg (oral tablet) 1T weekly and cholecalciferol 1000U/calcium 100mg 1T daily use. | Drug | Fosamax |
Primary outcome
Change of bone mineral density at lumbar spine
Time frame: 48 weeks
DEXA is used to evaluate the change of bone mineral density at lumbar spine after 48 weeks of drug intervention compared to those at baseline
2 secondary outcomes
Change of serum levels of bone turnover markers
Time frame: 24 and 48 weeks
Adherence to drug
Time frame: 24 and 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Derived from this study: PubMed 39589664Baek S, Ahn SH, Hong N, Seo DH, Hong S, Rhee Y. Efficacy and safety of weekly liquid alendronate in Korean postmenopausal women with osteoporosis: a 12-month, multi-center, randomized trial. Arch Osteoporos. 2024 Nov 26;19(1):119. doi: 10.1007/s11657-024-01480-6.
- 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.
Yumie Rhee principal investigator
Department of Internal Medicine, Endocrine Research Institute, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Masibone S and Fosamax in people with Osteoporosis, run by Yonsei University 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 May 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yumie Rhee (+82-2-2228-0883, yumie@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of bone mineral density at lumbar spine (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05387200, which also lists 1 linked publication.
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 31 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.