NCT05617846

Brief Summary

To report the postoperative complications and limb function of patients with osteolysis after surgery for bone tumors of the extremities who received anti-osteoporosis therapy in Henan Cancer Hospital in the next 10 years.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
78mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Dec 2024Nov 2032

First Submitted

Initial submission to the registry

October 31, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
2.1 years until next milestone

Study Start

First participant enrolled

December 28, 2024

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2032

Last Updated

January 18, 2024

Status Verified

August 1, 2023

Enrollment Period

7.9 years

First QC Date

October 31, 2022

Last Update Submit

January 16, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Complications

    The incidence of complications after anti-osteoporosis treatment was collected and the severity of complications was evaluated according to CTCAE5.0.

    Collected from the beginning of treatment to 24 months after treatment.

  • Limb function

    Limb function was assessed using the Musculoskeletal Oncology Society (MSTS) scoring scale for seven items, namely movement, pain, stability, deformity, strength, functional activity, and emotional receptiveness. The highest possible score is 35, with 5 points allocated to each project.

    Collected from the beginning of treatment to 24 months after treatment.

Study Arms (2)

Intervention group

Patients who received antiosteoporosis therapy after bone tumor resection

Other: Anti-osteoporosis therapy

Control group

Patients who underwent bone tumor resection without antiosteoporosis therapy

Interventions

Bone healing, limb function, and complications of postoperative osteolysis in patients with bone tumors of the extremities treated with anti-osteoporosis therapy.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving antiosteoporosis therapy for osteolysis after surgery for bone tumors in the extremities

You may qualify if:

  • No age restriction, male or female.
  • A subtype of bone tumor (including benign, malignant, and metastatic cancer) was confirmed in the pathology department of the research institution.
  • Received excision of bone tumor in research institution.

You may not qualify if:

  • Not applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Bone and Soft Tissue ,Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 16, 2022

Study Start

December 28, 2024

Primary Completion (Estimated)

November 30, 2032

Study Completion (Estimated)

November 30, 2032

Last Updated

January 18, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations