NCT01926158

Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women

Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women: a Randomized, Double-blind, Placebo-controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: Female
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial will evaluate the efficacy of an antiresorptive osteoporosis drug (denosumab) in prevention of periprosthetic bone loss and in promotion of implant osseointegration (bone bonding) in postmenopausal women after total hip replacement. The investigators assume that denosumab prevents periprosthetic bone loss and enhances bone bonding of the hip stem in postmenopausal women.

Detailed description

This is a randomized, double-blind and placebo-controlled trial to evaluate the efficacy of denosumab on the biologic incorporation of cementless hip prosthesis. The study population consists of sixty-eight postmenopausal female patients, who are scheduled to have cementless total hip replacement (THA) for primary hip osteoarthritis. The patients will be randomly assigned to receive a subcutaneous injection of denosumab 60 mg or placebo four weeks before surgery and 22 weeks after surgery. The primary hypothesis is that denosumab is effective in preventing periprosthetic bone loss in the proximal femur as measured by DXA. The secondary hypothesis is that denosumab is effective in enhancement of bone bonding (osseointegration) of cementless femoral stems, as measured by model-based radiostereometric analysis.

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
DRUG	Denosumb	Prefilled syringe of 1 mL denosumab solution
DRUG	Placebo (for denosumab)

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-02-04
• Completion: 2017-12-31
• First posted: 2013-08-20
• Last updated: 2018-04-30

Locations

1 site across 1 country: Finland

Regulatory

• FDA-regulated drug study