Application of Antiosteoporosis Therapy in Osteolysis

January 16, 2024 updated by: Wang Jiaqiang, Henan Cancer Hospital

Efficacy and Safety of Antiosteoporosis Therapy in Patients After Bone Tumor Resection: a Multicenter, Real-world Prospective Cohort Observational Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A total of 100 patients with osteolysis after surgery for bone tumors of the four extremities who received anti-osteoporosis treatment in Henan Cancer Hospital in the next 10 years were reported. The basic information, treatment methods, postoperative complications and limb function of these patients were collected.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Department of Bone and Soft Tissue ,Henan Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Not applicable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention group
Patients who received antiosteoporosis therapy after bone tumor resection
Other: Anti-osteoporosis therapy
Bone healing, limb function, and complications of postoperative osteolysis in patients with bone tumors of the extremities treated with anti-osteoporosis therapy.
Control group
Patients who underwent bone tumor resection without antiosteoporosis therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Collected from the beginning of treatment to 24 months after treatment.
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
Time Frame: Collected from the beginning of treatment to 24 months after treatment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 28, 2024

Primary Completion (Estimated)

November 30, 2032

Study Completion (Estimated)

November 30, 2032

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

November 14, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZZUSC-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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