Skip to content

Real-world studies of the efficacy, safety, and conversion of denosumab in cancer patients

Real-world studies of the efficacy, safety, and conversion of denosumab in cancer patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097786
Enrollment
Unknown
Registered
2025-02-25
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Giant cell tumor of bone, multiple myeloma or solid tumor with bone metastasis

Interventions

Grouping based on the duration of treatment with BPs converted to denosumab:None
Grouping based on whether the patient has experienced SRE in the past:None
Group patients according to their previous medication types:None
Group patients according to their disease type: giant cell tumor of bone, multiple myeloma, or solid tumor with bone metastasis.:None
Group patients according to the type of denosumab used: Angravi, Rudaxin, or other denosumab injections.:None

Sponsors

Zhengzhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed giant cell tumor of bone, multiple myeloma or bone metastasis of solid tumors, including but not limited to lung cancer, breast cancer, intestinal cancer, prostate cancer, liver cancer, esophageal cancer, etc., and need to be treated with denosumab; 2. Undergo imaging examinations such as computed tomography (CT), magnetic resonance imaging (MRI), X-ray, etc., indicating at least one bone metastasis or characteristic osteolytic lesion; 3. Age>=18 years old; 4. The performance status score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0-2; 5. Estimated survival time>=6 months.

Exclusion criteria

Exclusion criteria: 1. Severe heart, liver, kidney, lung and brain insufficiency; 2. Pregnant and lactating women; 3. Patients who are allergic to the study drug or who are prohibited from using the study drug in the instructions; 4. Have suffered or are currently suffering from osteomyelitis or osteonecrosis of the jaw; Dental or jaw disease in the active phase that requires oral surgery; Dental surgery or oral surgery wounds that have not healed; 5. Those with incomplete clinical data.

Design outcomes

Primary

MeasureTime frame
Types, frequency, and time of occurrence of bone related events (SREs) within 6 months.;

Secondary

MeasureTime frame
Types, frequency, and time of occurrence of bone related events (SREs) within 3 months;;At 3 and 6 months of treatment, serum calcium and phosphate ion concentrations, as well as serum alkaline phosphatase (ALP) levels, were compared to baseline;Compared to baseline bone density levels at 6 months of treatment;The median time from the first to the second SRE of the same type during the study period;Number of exacerbations of bone pain within 6 months;Types and severity of adverse reactions;

Countries

China

Contacts

Public ContactjiazhuanMEI

Zhengzhou People's Hospital

mjzhuan@163.com+86 371 67079876

Outcome results

None listed

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