The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty

The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty: A Randomised, Double Blind, Placebo Controlled Clinical Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02760979

Enrollment

Registered

2016-05-04

Start date

2013-01-31

Completion date

2015-06-30

Last updated

2017-08-11

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

Conditions

Bone Resorption

Keywords

knee arthroplasty

Brief summary

This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within a year after surgery.

Detailed description

Periprosthetic bone resorption after Total Knee Arthroplasty occurs as a consequence of prosthetic implant on the bone. Some of this patients (up to 13%) develop an aseptic failure of the prosthesis needing revision surgery. 2 groups of patients are treated with Placebo and Denosumab in a double blind prospective trial. Densitometry, Knee society score (KSS), Western Ontario McMaster University Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) were done in both groups at 0,3,6 and 12 months after surgery.

Interventions

DRUGDenosumab

Denosumab treatment one year after surgery

DRUGPlacebo

Serum one year after surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with Knee Osteoarthritis treated with Total Knee Arthroplasty

Exclusion criteria

* Patients allergies to Denosumab * Patients with previous Osteoporosis treatment * Patients with renal failure * Patients with previous Bisphosphonate treatment for more than 5 years

Design outcomes

Primary

Measure	Time frame	Description
Change in Bone Mass index	Change in densitometry before surgery (0) and at three (3) months after surgery	Bone Mass index in gr/cm3

Secondary

Measure	Time frame	Description
Quality of Life (WOMAC)	WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery	—
Quality of life (SF-36)	SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery	—
Kidney function	Before surgery and at three, six and twelve months after surgery	Creatinine clearance
Liver function	Before surgery and at three, six and twelve months after surgery	ALT, AST
Bone turnover markers	At three, six and twelve months after surgery	Beta cross lap and Procollagen type 1 n-terminal propeptide (P1NP)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026