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Efficacy and safety of Denosumab in cancer patients in the real world Sex and Conversion Therapy Research

Efficacy and safety of Denosumab in cancer patients in the real world Sex and Conversion Therapy Research

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097294
Enrollment
Unknown
Registered
2025-02-17
Start date
2025-02-24
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Tumour

Interventions

Observation group:NA

Sponsors

Shanghai No. 6 Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Confirmed by histology or cytology as bone giant cell tumor, multiple myeloma or solid tumor bone metastasis, solid tumor Including but not limited to lung cancer, breast cancer, bowel cancer, liver cancer, esophageal cancer, etc., and desulsuman antibody is required Perform treatment; 2.Receive imaging examinations such as computer tomography (CT), magnetic resonance imaging (MRI), X-ray, etc., and prompt to There is 1 less bone metastasis or characteristic osteolytic lesions; 3.Age>=18 years old; 4.Assessment of physical fitness status of Eastern Cooperative Oncology Group (ECOG) It is divided into 0-2 points; 5.The estimated survival time is>=6 months.

Exclusion criteria

Exclusion criteria: 1.Severe heart, liver, kidney, lung and brain insufficiency; 2.Pregnant women, breastfeeding women; 3.Patients who are allergic to research drugs or are prohibited from using research drugs in other instructions; 4.Past or currently suffering from osteomyelitis of jaw or osteonecrosis of jaw; in active period, oral hand needs to be performed dental or jaw disease; dental or oral surgery wounds have not healed; 5.Those with incomplete clinical data.

Design outcomes

Primary

MeasureTime frame
Types and timing of bone related events (SRE) within 6 months.;

Secondary

MeasureTime frame
Type and time of occurrence of bone related events (SRE) within 3 months.;At 3 or 6 months of treatment, urinary type I collagen cross-linked N-terminal peptide (uNTx/uCr) adjusted for urinary creatinine (uCr) percentage of change relative to baseline.;At 3 or 6 months of treatment, compared with baseline serum calcium, phosphorus ion concentrations and serum alkaline phosphatase (ALP) level.;Bone mineral density compared to baseline at 6 months of treatment.;Median time from first to second SRE of the same type during the study period;Bone pain worsens within 6 months;Types and severity of adverse reactions;

Countries

China

Contacts

Public ContactYang Qingcheng

Shanghai No. 6 Hospital

hongyan.lei@longleding.com+86 133 8994 2218

Outcome results

None listed

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