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Comparison of efficacy and safety of denosumab versus zoledronic acid in adjuvant therapy in patients with bone metastasis: a multi-center randomized controlled trial

Comparison of efficacy and safety of denosumab versus zoledronic acid in adjuvant therapy in patients with bone metastasis: a multi-center randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031557
Enrollment
Unknown
Registered
2020-04-04
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-04-06

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

Conditions

Bone metastasis

Interventions

zoledronic acid group:zoledronic acid
denosumab group:denosumab

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients with bone metastasis confirmed by histology or cytology were examined by X-ray, CT or MRI, which indicated that there was at least one bone metastasis or characteristic osteolytic lesion; 2. Patients who have bone related events and receive radiotherapy, surgery, chemotherapy, targeted therapy or multiple combination therapy; 3. The score of physical fitness in the Eastern Cooperative Oncology Group (ECoG) was 0-2 for patients with malignant tumors involving organs other than organs with good function; 4. Patients over 18 years old.

Exclusion criteria

Exclusion criteria: 1. Patients with primary bone tumor or hematological tumor; 2. Patients who had used zoledronic acid or dinosemide before this treatment; 3. Patients with expected survival less than 6 months; 4. Patients with mandibular necrosis.

Design outcomes

Primary

MeasureTime frame
OS;PFS;adverse reaction;

Secondary

MeasureTime frame
Frankel score;Vas score;QOL;

Countries

China

Contacts

Public ContactJianru Xiao

Department of Orthopaedic Oncology, Shanghai Changzheng Hospital

jianruxiao83@163.com+86 13701785283

Outcome results

None listed

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