SarcopeniaPhase 4NCT06272227
Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients
A Phase 4 study testing alfacalcidol and Denosumab in people with Sarcopenia, run by Yonsei University at 1 site in South Korea.
Trial summary
This study aims to investigate the potential improvement in muscle function, compared to the placebo group, through the concurrent administration of denosumab and alfacalcidol over a one-year period in postmenopausal women with functional sarcopenia and osteoporosis aged 65 and older. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Sarcopenia
- What is being tested?
- alfacalcidol and Denosumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Feb 2024to 1 Sep 2025
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 1) Females aged 65 and above. 2) Individuals with osteoporosis who are either currently on denosumab or planning to initiate denosumab treatment.
- 3) Participants committed to a minimum of 1-year denosumab treatment. 4) Those who have not taken any active vitamin D supplements within 3 months prior to the baseline visit (Visit 2).
- 5) Participants capable of walking. 6-1) Individuals with SPPB ≤ 9 meeting the criteria for low physical performance.
- 6-2) Individuals with SPPB scores of 10 or 11 and concurrently exhibiting low muscle strength (hand grip strength < 18kg) or gait speed < 1.0 m/s or chair stand test > 11s (sitting position) or a history of fractures (excluding skull, cervical spine, fingers, toes, and rib fractures) or a fall within the past year.
- 7) Individuals who have undergone DXA (Dual-energy X-ray Absorptiometry) within 6 months of the baseline visit (Visit 2).
- 8) Participants who, after receiving a detailed explanation of the clinical trial, have fully understood it, voluntarily decided to participate, and provided written consent to participate while agreeing to adhere to the precautions
Who cannot join
- Individuals contraindicated for active vitamin D supplementation:
- Patients with hypercalcemia or hyperphosphatemia. ② Those with a history of urolithiasis/nephrolithiasis.
- Individuals contraindicated for denosumab treatment:
- ① Those planning or with unresolved invasive dental procedures such as extractions, dental implants, or oral surgery.
- Individuals with hypoalbuminemia-corrected serum calcium outside the normal range.
- Individuals with vitamin D deficiency, defined as a serum 25(OH)D concentration below 12 ng/mL (30 nmol/L).
Show all 16Show fewer
- Participants who have received continuous prednisolone (or equivalent glucocorticoid) at a dose of 5 mg or higher per day for at least 90 days within 6 months of the screening visit (Visit 1).
- Individuals with severe malnutrition, indicated by a serum albumin level of 3.0 mg/dL or below.
- Those in an acute immobility state due to reasons such as fracture, hospitalization, or surgery within 1 month of the baseline visit (Visit 2).
- Individuals with severe underlying conditions:
- ① Patients with metastatic cancer.
- ② Those with severe renal impairment (estimated Glomerular Filtration Rate; eGFR) less than 15 mL/min/1.73m² or undergoing dialysis.
- ③ Individuals receiving oxygen therapy due to chronic obstructive pulmonary disease (COPD).
- ④ Those with decompensated liver cirrhosis and severe liver disease with complications due to portal hypertension
- Individuals with physical limitations due to specific conditions other than muscle decline: ① Those incapable of communication, including severe dementia. ② Individuals undergoing drug therapy for neuro-muscular disorders such as Parkinson's disease or severe myasthenia.
- Individuals with an SPPB score of 12, indicating no impairment in physical function
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Endocrinology, Department of internal Medicine, Yonsei University College of Medicine, Severance Hospital
Seoul, 03722
About this study
Official title: Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients; Double-blinded Randomized Controlled Trial
This study aims to investigate the potential improvement in muscle function, compared to the placebo group, through the concurrent administration of denosumab and alfacalcidol over a one-year period in postmenopausal women with functional sarcopenia and osteoporosis aged 65 and older. The study is planned as a double-blinded randomized controlled trial, intending to recruit a total of 340 participants. Primary outcome is the improvement in SPPB score of 0.5 or more compared to the control group.
Read the detailed description
This trial is a double-blind, randomized phase 4 trial to evaluate whether alfacalcidol co-administration improves muscle function compared to the placebo group in functional sarcopenia women over 65 years of age who are taking denosumab for osteoporosis. This trial consists of four trial periods (Screening Visit 1, Baseline Visit 2, Visit 3 (26 weeks), and Visit 4 (52 weeks).
- Conditions
- Sarcopenia
- Being tested
- alfacalcidol, placebo, Denosumab
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alfacalcidolDrug
Subjects assigned to arm 1 take two doses of alfacalcidol once a day for a total of 52 weeks from the day after baseline visit 2 to the day before the end of the test (visit 4).
placeboDrug
Subjects assigned to arm 2 take two doses of placebo once a day for a total of 52 weeks from the day after baseline visit 2 to the day before the end of the test (visit 4).
DenosumabDrug
denosumab
| Study group | Role | What they receive |
|---|---|---|
| alfacalcidol | Experimental | alfacalcidol plus denosumab Receives: Drug: alfacalcidol; Drug: Denosumab |
| placebo | Placebo comparator | placebo + denosumab Receives: Drug: placebo; Drug: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in SPPB score of 0.5 or more compared to the control group
Our study aim is to demonstrate the improvement in SPPB(Short physical performace battery) score of 0.5 or more in the alfacalcidol group compared to the placebo group.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start13 Feb 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272227
- Sponsor's protocol ID
- 4-2023-0986
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients; Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06272227
- Acronym / sponsor ID
- 4-2023-0986
- Conditions
- Sarcopenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Feb 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 22 Feb 2024 (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 investigate the potential improvement in muscle function, compared to the placebo group, through the concurrent administration of denosumab and alfacalcidol over a one-year period in postmenopausal women with functional sarcopenia and osteoporosis aged 65 and older. The study is planned as a double-blinded randomized controlled trial, intending to recruit a total of 340 participants. Primary outcome is the improvement in SPPB score of 0.5 or more compared to the control group.
Detailed description
This trial is a double-blind, randomized phase 4 trial to evaluate whether alfacalcidol co-administration improves muscle function compared to the placebo group in functional sarcopenia women over 65 years of age who are taking denosumab for osteoporosis. This trial consists of four trial periods (Screening Visit 1, Baseline Visit 2, Visit 3 (26 weeks), and Visit 4 (52 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alfacalcidol | Experimental | Drug: alfacalcidol, Drug: Denosumabalfacalcidol plus denosumab |
| placebo | Placebo comparator | Drug: placebo, Drug: Denosumabplacebo + denosumab |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 1) Females aged 65 and above. 2) Individuals with osteoporosis who are either currently on denosumab or planning to initiate denosumab treatment.
- 3) Participants committed to a minimum of 1-year denosumab treatment. 4) Those who have not taken any active vitamin D supplements within 3 months prior to the baseline visit (Visit 2).
- 5) Participants capable of walking. 6-1) Individuals with SPPB ≤ 9 meeting the criteria for low physical performance.
- 6-2) Individuals with SPPB scores of 10 or 11 and concurrently exhibiting low muscle strength (hand grip strength < 18kg) or gait speed < 1.0 m/s or chair stand test > 11s (sitting position) or a history of fractures (excluding skull, cervical spine, fingers, toes, and rib fractures) or a fall within the past year.
- 7) Individuals who have undergone DXA (Dual-energy X-ray Absorptiometry) within 6 months of the baseline visit (Visit 2).
Key exclusion criteria (16 listed)
- Individuals contraindicated for active vitamin D supplementation:
- Individuals contraindicated for denosumab treatment:
- ① Those planning or with unresolved invasive dental procedures such as extractions, dental implants, or oral surgery.
- Individuals with vitamin D deficiency, defined as a serum 25(OH)D concentration below 12 ng/mL (30 nmol/L).
- Participants who have received continuous prednisolone (or equivalent glucocorticoid) at a dose of 5 mg or higher per day for at least 90 days within 6 months of the screening visit (Visit 1).
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 |
|---|---|---|
| alfacalcidolSubjects assigned to arm 1 take two doses of alfacalcidol once a day for a total of 52 weeks from the day after baseline visit 2 to the day before the end of the test (visit 4). | Drug | alfacalcidol |
| placeboSubjects assigned to arm 2 take two doses of placebo once a day for a total of 52 weeks from the day after baseline visit 2 to the day before the end of the test (visit 4). | Drug | placebo |
| Denosumabdenosumab | Drug | alfacalcidol, placebo |
Primary outcome
Improvement in SPPB score of 0.5 or more compared to the control group
Time frame: one year
Our study aim is to demonstrate the improvement in SPPB(Short physical performace battery) score of 0.5 or more in the alfacalcidol group compared to the placebo group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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.
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 alfacalcidol and Denosumab in people with Sarcopenia, 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 6 inclusion and 16 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 22 Feb 2024. 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. Some participants in this study may receive a placebo. 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 (+82-02-2228-1973, yumie@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in SPPB score of 0.5 or more compared to the control group (time frame: one year). 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 22 Feb 2024.