Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients

NCT06272227 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 4-2023-0986
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Study Arms (2)

alfacalcidol

EXPERIMENTAL

alfacalcidol plus denosumab

Drug: alfacalcidol; Drug: Denosumab

placebo

PLACEBO COMPARATOR

placebo + denosumab

Drug: placebo; Drug: Denosumab

Interventions

alfacalcidol DRUG

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).

alfacalcidol

placebo DRUG

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).

placebo

Denosumab DRUG

denosumab

alfacalcidol; placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \) Females aged 65 and above. 2) Individuals with osteoporosis who are either currently on denosumab or planning to initiate denosumab treatment.
• \) 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).
• \) Participants capable of walking. 6-1) Individuals with SPPB ≤ 9 meeting the criteria for low physical performance.
• ) 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.
• \) Individuals who have undergone DXA (Dual-energy X-ray Absorptiometry) within 6 months of the baseline visit (Visit 2).
• \) 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Endocrinology, Department of internal Medicine, Yonsei University College of Medicine, Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

alfacalcidol; Denosumab

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yumie Rhee

CONTACT

+82-02-2228-1973; yumie@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 22, 2024
• Study Start: February 13, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)