A Phase 4 interventional study of Denosumb and Placebo (for denosumab) in Hip Osteoarthritis, sponsored by Turku University Hospital. Completed at 1 site in Finland. Open to female participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-04-30.
Sponsored by Turku University Hospital · Phase 4, Interventional, and Prevention
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 65 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use within 12 months of drugs that affect bone metabolism such as ant-osteoporotic agents (including SERMS), estrogens, testosterone, and anti-epileptics:
Use of the following medications:
General
Subcutaneous injection of denosumab 60 mg 4 weeks before surgery and 22 weeks after surgery
Drug: Denosumb
Subcutaneous injection of placebo 4 weeks before surgery and 22 weeks after surgery
Drug: Placebo (for denosumab)
Prefilled syringe of 1 mL denosumab solution
Also known as: Brand name: Prolia
Also known as: Prefilled syringe of 1 mL placebo solution
Periprosthetic bone mineral density (BMD)
Periprosthetic BMD of the proximal femur will be measured according to seven Gruen zones and compared with the baseline value
Time frame: 48 weeks
Radiostereometric analysis (RSA) of prosthesis stem migration
The translatory and rotatory migration of the femoral stem will be measured by means of model-based RSA and compared with the position at the baseline
Time frame: 48 weeks
Functional recovery
To investigate if the enhanced incorporation of hip prostheses in denosumab treated patients compared to placebo leads to faster functional recovery as measured by main parameters of gait analysis, pedometer evaluation of walking activity and patient reported outcome measures
Time frame: 48 weeks
Plan to share: No
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Turku University Hospital