NCT02760979

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2013

Typical duration for phase_4

Status
completed

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 Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

April 28, 2016

Last Update Submit

August 10, 2017

Conditions

Bone Resorption

Keywords

knee arthroplasty

Outcome Measures

Primary Outcomes (3)

  • Change in Bone Mass index

    Bone Mass index in gr/cm3

    Change in densitometry before surgery (0) and at three (3) months after surgery

  • Change in Bone Mass index

    Bone Mass index in gr/cm3

    Change in densitometry before surgery (0) and at six (6) months after surgery

  • Change in Bone Mass index

    Bone Mass index in gr/cm3

    Change in densitometry before surgery (0) and at twelve (12) months after surgery

Secondary Outcomes (5)

  • 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

  • Liver function

    Before surgery and at three, six and twelve months after surgery

  • Bone turnover markers

    At three, six and twelve months after surgery

Study Arms (2)

Denosumab

ACTIVE COMPARATOR

Patients treated with Denosumab

Drug: Denosumab

Placebo

PLACEBO COMPARATOR

Patients treated with placebo

Drug: Placebo

Interventions

DenosumabDRUG

Denosumab treatment one year after surgery

Also known as: Prolia
Denosumab
PlaceboDRUG

Serum one year after surgery

Also known as: Serum
Placebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Knee Osteoarthritis treated with Total Knee Arthroplasty

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Ishii Y, Yagisawa K, Ikezawa Y. Changes in bone mineral density of the proximal femur after total knee arthroplasty. J Arthroplasty. 2000 Jun;15(4):519-22. doi: 10.1054/arth.2000.4639.

    PMID: 10884214BACKGROUND

  • Sugita T, Umehara J, Sato K, Inoue H. Influence of tibial bone quality on loosening of the tibial component in total knee arthroplasty for rheumatoid arthritis: long-term results. Orthopedics. 1999 Feb;22(2):213-5. doi: 10.3928/0147-7447-19990201-10.

    PMID: 10037335BACKGROUND

  • Wang CJ, Wang JW, Weng LH, Hsu CC, Huang CC, Chen HS. The effect of alendronate on bone mineral density in the distal part of the femur and proximal part of the tibia after total knee arthroplasty. J Bone Joint Surg Am. 2003 Nov;85(11):2121-6. doi: 10.2106/00004623-200311000-00009.

    PMID: 14630840BACKGROUND

MeSH Terms

Conditions

Bone Resorption

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jose Carlos Gonzalez

    Orthopaedic Department-Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2016

First Posted

May 4, 2016

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

June 1, 2015

Last Updated

August 11, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share