Effects of Denosumab on Periprosthetic Bone After Total Hip Arthroplasty

NCT01630941 | Completed Phase 2

• 1 other identifier: 2011-001481-18
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to study the effect of Denosumab on Bone Mineral Density, Standardised Uptake Value and bone metabolism in patients with total hip arthroplasty. The primary hypothesis is to demonstrate that Denosumab is superior to placebo.

Conditions

Osteoarthritis, Hip; Ambulation Difficulty

Keywords

Osteoarthritis of the hip; Uncemented Total Hip Arthroplasty; DXA; BMD; PET; CT; Biochemical bone markers

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density

  Bone mineral density by DXA in Gruen Zone 7 and a sum of Gruen zone 1-7

  12 months

Secondary Outcomes (11)

• Bone mineral Density

  24 months

• Standardised Uptake value

  6 months

• Standardised Uptake value

  6 months

• Bone Mineral density

  24 months

• Bone Mineral Density

  24 months

Study Arms (2)

Denosumab

ACTIVE COMPARATOR

1 ml (60 mg) subcutaneous injection Denosumab give in the posterior part of the upper arm after surgery followed by another injection 6 months later

Drug: denosumab

saline

PLACEBO COMPARATOR

1 ml subcutaneous injection 0.9% saline give in the posterior part of the upper arm after surgery followed by another injection 6 months later

Drug: denosumab

Interventions

denosumab DRUG

Two doses of 60 mg in a solution of 1 ml, given as an subcutaneous injection with a 6 month interval

Also known as: Prolia

Denosumab; saline

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female patient 35-65 years of age with an unilateral OAH requiring a THA and a healthy contralateral hip
• body weight ≤110 kg or body mass index (BMI) ≤35 kg/m2
• living in the Uppsala County
• the eligible patients should have been given oral information, a written Patient Information and signed an Informed Consent

You may not qualify if:

• on or previously have had bone-specific treatment, e.g. bisphosphonates, raloxifene, parathyroid hormone, strontium ranelate, during the last five years
• patients on systemical corticosteroid for more than 3 months should not be considered
• patients with diagnosed malignant disease during the last five years or known to have metastasis from malignant disease should be excluded
• patients with compromised general conditions and an American Society of Anesthesiologists, ASA-score \>31 should not be regarded eligible
• patients with known drug or alcohol abuse or regarded as socially dysfunctional, as judged by the investigator, should not be considered for the study
• pregnant women or women planning for pregnancy or fertile women (premenopausal) without contraceptives should not be accepted for the study
• patients that have been exposed frequently and/or have had large irradiation doses, as judged by the investigator, must not be included in the study.
• enrolled in either another investigational drug study, in another investigational device study, or in another investigational study of an approved drug within 30 days prior to Visit 1 of the current study

Sponsors & Collaborators

• Hans Mallmin: lead

Study Sites (1)

Department of Orthopedics

Uppsala, Sweden

Location

Related Publications (2)

• Kultima K, Ashtiani SH, Erngren I, Khoonsari PE, Carlsson H, Herman S, Freyhult E, Mallmin H, Hailer NP. Uncemented hip arthroplasty and denosumab: increased postoperative dipeptide concentrations and identification of potential new bone turnover biomarkers. JBMR Plus. 2025 May 19;9(7):ziaf091. doi: 10.1093/jbmrpl/ziaf091. eCollection 2025 Jul.

  PMID: 40584156 DERIVED

• Nystrom A, Kiritopoulos D, Ullmark G, Sorensen J, Petren-Mallmin M, Milbrink J, Hailer NP, Mallmin H. Denosumab Prevents Early Periprosthetic Bone Loss After Uncemented Total Hip Arthroplasty: Results from a Randomized Placebo-Controlled Clinical Trial. J Bone Miner Res. 2020 Feb;35(2):239-247. doi: 10.1002/jbmr.3883. Epub 2019 Nov 4.

  PMID: 31589776 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip; Mobility Limitation

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hans Mallmin, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

• Nils Hailer, MD, PhD

  Uppsala University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: August 7, 2012
• Primary Completion: January 16, 2017
• Study Completion: March 30, 2017
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

SE (1)