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NCT01358669COMPLETEDanonymous

Effect of Denosumab on Inflammatory Osteolytic Lesion Activity in Total Hip

Sponsor

Source record

Sheffield Teaching Hospitals NHS Foundation Trust

Phase

Source record

PHASE2

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Denosumab, Placebo

Indication / condition

AI-normalized

Revision Surgery of Total Hip Arthroplasty

Intervention

Source record

Denosumab, Placebo

Source & freshness

Source record

NCT ID

NCT01358669

Original source

ClinicalTrials.gov

Source last updated

Aug 29, 2022

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT01358669

Title

Effect of Denosumab on Inflammatory Osteolytic Lesion Activity in Total Hip

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Status

COMPLETED

Phase

PHASE2

Condition raw

Revision Surgery of Total Hip Arthroplasty

Condition normalized

Revision Surgery of Total Hip Arthroplasty

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Denosumab, Placebo

Target normalized

Denosumab, Placebo

Interventions

Denosumab, Placebo

Public preview

Source record

Although hip replacement surgery is a successful way of dealing with the pain and immobility caused by hip arthritis, 10% of the hip replacements carried out in the UK fail within 10 years. The main reason for this is the development periprosthetic osteolysis, that is, loss of bone around the site of the hip replacement. The osteolysis is thought to be due to the small particles of debris worn from the surfaces of the hip implant. These particles cause a reaction in the blood cells around the joint which in turn affects bone cells and leads to a loss of bone around the implant. The joint implant will then eventually become loose and unstable, a condition known as aseptic loosening. At present the only way to treat aseptic loosening is to have another operation to secure the hip joint, known as revision surgery. Revision surgery is not always successful and exposes the patient to the risk of major surgery.

In this study we explore the potential for giving a medication (denosumab) that may prevent the loss of bone around the hip replacement implant. We will recruit patients who have been listed for revision surgery. One group of patients will be given a single dose of denosumab; another group will be given a placebo (dummy drug). At the time of the revision surgery a small sample of the bone from around the hip replacement will be taken and examined under the microscope. Comparisons will be made between the patients having the denosumab and those having placebo to find out whether the denosumab is having a beneficial effect on the bone surfaces. If successful, this study will lead to further studies to develop the use of denosumab to prevent aseptic loosening.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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