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Clinical study on dynamic monitoring of bone turnover markers in the diagnosis and treatment of osteoporosis and osteoporotic fracture

Clinical study on dynamic monitoring of bone turnover markers in the diagnosis and treatment of osteoporosis and osteoporotic fracture

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099711
Enrollment
Unknown
Registered
2025-03-27
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Osteoporosis

Interventions

Cohort study group:All patients received desuzumab 60 mg subcutaneous injection once every 6 months for 12 months
Supplement calcium (1000 mg) and vitamin D(800 IU) daily.
Control group (cohort study+randomized controlled study):All patients received desuzumab 60 mg subcutaneous injection once every 6 months for 12 months
Intervention group (Randomized controlled study):Individualized adjustment according to the change of BTMs.

Sponsors

Xuzhou Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1 Age >= 50 years, diagnosed as primary osteoporosis (BMD T value of lumbar spine or hip <= -2.5, or a history of brittle fracture); 2 No severe liver and kidney dysfunction, and no systemic anti-osteoporosis treatment; 3 Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: 1 Secondary osteoporosis (such as hyperthyroidism and long-term hormone use); 2 severe hepatic and renal insufficiency (EGFR < 30 ml/min/1.73 m^2); 3 Suffering from malignant tumor or other diseases that seriously affect bone metabolism; 4 Anti-osteoporosis drug allergy; 5 mental illness or cognitive impairment, unable to cooperate with the research process; 6 Expected survival time < 2 years.

Design outcomes

Primary

MeasureTime frame
New osteoporotic fracture rate;

Secondary

MeasureTime frame
Procollagen type 1 N-terminal propeptide(P1NP);Type I collagen carboxyterminalpeptide(CTX);Thyrocalcitonin;25 hydroxyvitamin d;Osteocalcin;Parathyroid hormone;Bone mineral density;mDIXON-Quant;Changes in bone mineral density in the hip (BMD);

Countries

China

Contacts

Public ContactShimin Li

Xuzhou Cancer Hospital

1019424569@qq.com+86 198 3451 9064

Outcome results

None listed

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