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A Real-World Study of Migu Capsules Combined with Denosumab in Treatment of Dysmobility Syndrome

A Real-World Study of Migu Capsules Combined with Denosumab in Treatment of Dysmobility Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083781
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmobility Syndrome

Interventions

Experimental group:Migu capsules combined with denosumab

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged 60-90 years; 2. Meet the diagnosis of "osteoporotic-type" Dysmobility Syndrome: must meet criterion ?, and any two of criteria ?????: ? Osteoporosis: DXA measurement showing total T value = -2.5 at the lumbar spine, femoral neck, or proximal femur. ? History of falls: At least one fall in the past year. ? Slow gait speed: Gait speed 30% for males, > 40% for females. 3. Capability of performing basic daily activities independently or with the assistance of others and assistive devices. 4. Those who voluntarily participated in this study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Not suitable for injection of denosumab in cases of unhealed dental or oral surgical wounds, hypocalcemia, or allergy to denosumab. 2.Allergic to Migu capsules. 3.Dominant neurological disorders (such as stroke and peripheral neuropathy), joint diseases (such as osteoarthritis), and vascular diseases (such as peripheral vascular disease) leading to varying degrees of functional impairment of the musculoskeletal system. 4.Limb disabilities (missing limbs or paralysis, deformities) leading to varying degrees of functional impairment of the musculoskeletal system. 5.Presence of spinal bone lesions such as spinal tuberculosis, spinal tumors, spinal cord tumors, detected by imaging examinations. 6.Patients with severe metabolic bone diseases such as primary hyperparathyroidism, hyperthyroidism, etc. 7. Patients with serious cardiovascular, cerebrovascular, liver, kidney, hematopoietic, digestive system and other diseases, or cognitive impairment and mental illness. 8.Unwilling to participate in this trial. 9.Other situations that the researcher considers unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Fall;Fracture;Bone mineral density;Grip strength;

Secondary

MeasureTime frame
Gait speed;Body composition analysis;5-time Chair Standing Test;Calf circumference;ADL;IADL;Movement information;SF36 Quality of Life Scale;Deficiency syndrome scale;Fracture risk;MNA-SF;Biochemical bone markers;

Countries

China

Contacts

Public ContactYongfang Zhao

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

zhao_dingding@126.com+86 135 0181 9578

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026