Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients
Status: Not yet recruiting

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.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  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  Exclusion Criteria:  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. Individuals with an SPPB score of 12, indicating no impairment in physical function - HealthyVolunteers: No - Gender: Female - MinimumAge: 65 Years - StdAgeList: Older Adult