Denosumab for Treating Periprosthetic Osteolysis.

NCT02299817 | Unknown Phase 2

• 1 other identifier: EudraCT No: 2013-004940-48
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to study the efficacy of denosumab in reducing wear-induced osteolysis around uncemented acetabular implants used in total hip arthroplasty. Patients included in the study will receive the same dose of 60 mg denosumab or placebo (1 ml solution) for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months. The primary endpoint will be the change in volume of the osteolytic lesion over 3 years measured (measured with 3D-CT in cm³).

Conditions

Osteolysis

Outcome Measures

Primary Outcomes (1)

• Volume of the osteolytic lesion

  The change in volume of the osteolytic lesion over 3 years (measured with 3D-CT in cm³) is the primary endpoint variable: E〖fficacy〗\_(3 years)=〖Volume〗\_(3 years)-〖Volume〗\_baseline.

  3 years

Secondary Outcomes (3)

• Volume of the osteolytic lesion

  2 years

• Percentage change of the lesion over the study period

  3 years

• Adverse events

  3 years

Study Arms (2)

Denosumab

ACTIVE COMPARATOR

Patients will receive a dose of 60 mg denosumab (1 ml solution) for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months.

Drug: Denosumab

Placebo

PLACEBO COMPARATOR

Patients will receive a dose of placebo (1 ml solution) for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months.

Drug: Placebo

Interventions

Denosumab DRUG

Prolia is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fracture (broken bones). In women who have been through the menopause Prolia reduces the risk of fractures in the spine and elsewhere in the body, including in the hip. Prolia is also used to treat bone loss in men receiving treatment for prostate cancer that increases their risk of fracture. Prolia reduces the risk of fractures in the spine. Recently denosumab was found to be effective in preventing osteoporosis related fractures in post-menopausal women by blocking RANKL and thereby inhibiting the development and activity of osteoclast.

Also known as: Prolia

Denosumab

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-85 years
• Short Portable Mental Status Questionnaire (SPMSQ) also named pfeiffers test ≥7
• Male and females
• The primary total hip arthroplasty performed due to osteoarthritis or congenital dysplasia of the hip.
• Uncemented cup fixation
• Baseline osteolytic lesion of at least 4 cm³ and at most 40 cm³ around an uncemented acetabular component with a polyethylene liner.
• Participant is willing and able to follow study protocol and has provided informed consent prior to any study specific procedures.

You may not qualify if:

• For women of childbearing potential: Subject refuses to use 1 highly effective method of contraception (contraceptive pill, intra uterine contraceptive device) for the duration of the study and for 10 months after the last dose of study medication.
• For males with a partner of childbearing potential: Subject refuses to use a condom for the duration of the study and for 10 months after the last dose of study medication.
• For males with a partner who is pregnant: Subject refuses to use a condom for the duration of the study and for 10 months after the last dose of study medication.
• Pain in the operated hip (because the presence of hip pain in combination with an osteolytic lesion is an indication for revision surgery). VAS \>3
• Previous revision surgery of the hip i.e. exchange of any inplant after the primary surgery
• Inflammatory arthritis
• Previous participation in clinical trials with denosumab or administration of commercial denosumab (Prolia™ or Xgeva™)
• Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
• Administration of any of the following treatments 3 months prior to screening:
• Anabolic steroids or testosterone
• Glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of ≥ 50 mg)
• Calcitonin
• Calcitriol or vitamin D derivatives \[vitamin D contained in supplements or multivitamins is allowed\]
• Other bone active drugs including anti convulsive (except benzodiazepines) and heparin
• Chronic systemic ketoconazole, adrenocorticotrophic hormone, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists.

Sponsors & Collaborators

• Olof Skoldenberg: lead
• Danderyd Hospital: collaborator

Study Sites (1)

Danderyd Hospital

Stockholm, 182 88, Sweden

Location

Related Publications (2)

• Axenhus M, Boden H, Kelly-Pettersson P, Skoldenberg O. Denosumab for treating periprosthetic osteolysis: a feasibility study. BMC Res Notes. 2025 Apr 8;18(1):151. doi: 10.1186/s13104-025-07216-0.

  PMID: 40200363 DERIVED

• Skoldenberg O, Rysinska A, Eisler T, Salemyr M, Boden H, Muren O. Denosumab for treating periprosthetic osteolysis; study protocol for a randomized, double-blind, placebo-controlled trial. BMC Musculoskelet Disord. 2016 Apr 23;17:174. doi: 10.1186/s12891-016-1036-5.

  PMID: 27108405 DERIVED

MeSH Terms

Conditions

Osteolysis

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Olof Sköldenberg, MD, Ph.D

  Danderyds Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: August 1, 2015
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

SE (1)