Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women: a Randomized, Double-blind, Placebo-controlled Study
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Turku University Hospital
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Periprosthetic bone mineral density (BMD)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 85 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Postmenopausal women, age: ≥ 60 years to ≤ 85 years at randomization
- •Degenerative primary hip osteoarthritis as the indication of hip replacement
- •Signed informed consent
Exclusion Criteria
- •Presence of severe osteoporosis (T-score less than -4.0 and a previous fracture)
- •Presence of Dorr C-type geometric change of the proximal femur
- •Evidence of secondary osteoporosis
- •Clinical or laboratory evidence of hepatic disease
- •Laboratory evidence of hypocalcaemia
- •Vitamin D deficiency (serum 25-OH(D) \< 12 ng/mL)
- •Disorders of parathyroid function
- •Uncontrolled hyperthyroidism or hypothyroidism
- •History of malignancy, radiotherapy or chemotherapy for malignancy (except basal cell carcinoma of the skin) within the last 5 years
- •History of osteonecrosis of the jaw
Arms & Interventions
Denosumab
Subcutaneous injection of denosumab 60 mg 4 weeks before surgery and 22 weeks after surgery
Intervention: Denosumb (Drug)
Placebo
Subcutaneous injection of placebo 4 weeks before surgery and 22 weeks after surgery
Intervention: Placebo (for denosumab) (Drug)
Outcomes
Primary Outcomes
Periprosthetic bone mineral density (BMD)
Time Frame: 48 weeks
Periprosthetic BMD of the proximal femur will be measured according to seven Gruen zones and compared with the baseline value
Secondary Outcomes
- Radiostereometric analysis (RSA) of prosthesis stem migration(48 weeks)