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Efficacy and safety of digital therapy in the prevention and treatment of fracture risk in postmenopausal women with osteoporosis

Efficacy and safety of digital therapy in the prevention and treatment of fracture risk in postmenopausal women with osteoporosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082832
Enrollment
Unknown
Registered
2024-04-09
Start date
2024-04-10
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Osteoporosis in postmenopausal women

Interventions

Trial group: received DTx+ disuzumab injection (Lukexin) 60mg each time
Control group:Disuzumab injection (Lukexin) 60mg each time

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Voluntarily sign an informed consent form (ICF) and be able to comply with treatment protocols, visits, laboratory tests, and other requirements specified in the study; (2) Age =45 years, =75 years; (3) Postmenopausal women; (4) Bone mineral density test value T value: -2.5 ~ -4.0.

Exclusion criteria

Exclusion criteria: (1) Allergic reaction to any component of disuzumab injection; (2) Patients with hypocalcemia; (3) Patients whose spinal x-rays reveal any severe or more than two moderate vertebral fractures; (4) Hearing or visual impairment, physical disability and Parkinson's disease; (5) expression disorder or mental illness; (6) It is estimated that the compliance of participants to participate in the clinical study is insufficient; (7) Participants who are currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Bone mineral density;roentgenogram;

Secondary

MeasureTime frame
Pittsburgh sleep index;Heart sunshine index;Quality of Life Scale (SF-12);Standing and Walking Test Assessment Scale (TUG);Muscle strength test;FRAX Risk Assessment;

Countries

China

Contacts

Public ContactFuxing Pei

West China Hospital of Sichuan University

peifuxing@vip.163.com+86 189 8060 1380

Outcome results

None listed

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