Effects of Denosumab on Periprosthetic Bone After Total Hip Arthroplasty

Status Completed

Clinical Trial 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.

Clinical Trial Description

A clinical study with 64 patients, age 35-65 years, with unilateral osteoarthritis of the hip, randomised to two groups of patients, either receiving Denosumab or placebo

The patients will operated with an uncemented total hip arthroplasty with a Continuum acetabular cup with trabecular surface (Tantalum) and longevity Highly Cross-linked Polyethylene liner, Zimmer, Warsaw, IN, USA, and a CFP femoral stem with Titanium surface and a chrome cobalt 28 mm head, Waldemar Link, Hamburg, Germany.

Clinical outcome evaluated by Harris Hip Score and EQ-5D, Bone Mineral Density by DXA, Standardised Uptake Value of Fluoride tracer, by PET/CT and biochemical markers for bone formation and bone resorption will be analyzed together with conventional radiology for implant position and fixation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01630941
Study type	Interventional
Source	Uppsala University Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	August 7, 2012
Completion date	March 30, 2017

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05773261` - Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups	N/A
Recruiting	`NCT05223777` - KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA)	N/A
Recruiting	`NCT04731077` - Avenir Complete Post-Market Clinical Follow-Up Study	N/A
Not yet recruiting	`NCT04448106` - Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis	Phase 2
Completed	`NCT05070871` - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women	N/A
Not yet recruiting	`NCT06162195` - The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement	N/A
Withdrawn	`NCT02743208` - Evaluation of a Short Femoral Stem in Total Hip Arthroplasty	N/A
Completed	`NCT02944448` - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee	Phase 2
Active, not recruiting	`NCT02229279` - Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures	N/A
Active, not recruiting	`NCT02851992` - A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem	N/A
Completed	`NCT01700933` - Dose-response: Exercise Therapy on Hip Osteoarthritis	N/A
Completed	`NCT01618708` - A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip	N/A
Completed	`NCT01214954` - Early Rehabilitation After Total Hip Replacement	N/A
Active, not recruiting	`NCT00294424` - Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements	N/A
Terminated	`NCT00588861` - Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement	N/A
Withdrawn	`NCT05054595` - Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention	N/A
Terminated	`NCT00973141` - A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain	Phase 2
Recruiting	`NCT05014113` - H-28 DELTA ST-C and Minima Retrospective Study.
Completed	`NCT01066936` - Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
Recruiting	`NCT06185036` - Histological Validation of dGEMRIC Indices as a Quantitative Biomarker for Cartilage Damage in the Hip Joint