Abstract
ABSTRACTAntiresorptive denosumab is known to improve the quality and strength of cortical bone in the proximal femurs of osteoporotic women, but its efficacy in preventing periprosthetic bone loss and reducing femoral stem migration has not been studied in women undergoing cementless total hip arthroplasty. We conducted a single‐center, randomized, double‐blinded, placebo‐controlled trial of 65 postmenopausal women with primary hip osteoarthritis and Dorr type A or B proximal femur anatomy. The patients randomly received subcutaneous injections of denosumab 60 mg or placebo once every 6 months for 12 months, starting 1 month before surgery. The primary endpoint was the change in bone mineral density (BMD) of the proximal femur (Gruen zone 7) at week 48, and the secondary endpoint was stem subsidence measured by radiostereometric analysis (RSA) at week 48. Exploratory endpoints included changes in BMDs of the contralateral hip, lumbar spine and distal radius, serum levels of bone turnover markers, walking speed, walking activity, patient‐reported outcome measures, and radiographic assessment of stem osseointegration. The participants underwent vertebral‐fracture assessment in an extension safety study at 3 years. Denosumab significantly decreased bone loss in the medial femoral neck (zone 7) and increased periprosthetic BMD in the greater trochanteric region (zone 1) and lesser trochanteric region (zone 6). Denosumab did not reduce temporary femoral stem migration. The migration occurred mainly during the settling period (0 to 12 weeks) after implantation of the prosthesis. All of the stems osseointegrated, as evaluated by RSA and radiographs. There were no intergroup differences in functional recovery. Discontinuation of denosumab did not lead to any adverse events. In conclusion, denosumab increased periprosthetic BMD in the clinically relevant regions of the proximal femur, but the treatment response was not associated with any reduction of initial stem migration. © 2019 The Authors. JBMR Plus published by Wiley Periodicals, Inc. on behalf of the American Society for Bone and Mineral Research.
Highlights
Total hip arthroplasty is one of the most commonly performed elective surgical procedures.[1]
Antiresorptive denosumab is the first biologic therapy approved for postmenopausal osteoporosis.[25]. Reflecting a fundamentally different mechanism of action,(26) denosumab has a stronger influence on cortical bone remodeling than alendronate.[27,28] In the proximal femur of postmenopausal women, osteoporotic cortical bone responds rapidly to denosumab therapy by decreasing intracortical porosity[29] and increasing bone volume and strength.[30]
We hypothesized that denosumab could have a dual effect in postmenopausal women undergoing cementless total hip arthroplasty, namely by preventing periprosthetic bone resorption and thereby reducing the amount of initial femoral stem migration occurring before osseointegration
Summary
Total hip arthroplasty is one of the most commonly performed elective surgical procedures.[1]. Hip osteoarthritis does not protect postmenopausal women from developing concomitant osteoporosis.[6,7] In cementless total hip arthroplasty, osteoporotic cortical bone[5,8,9] may pose difficulties in achieving axial and rotational stability of femoral stems. We hypothesized that denosumab could have a dual effect in postmenopausal women undergoing cementless total hip arthroplasty, namely by preventing periprosthetic bone resorption (primary endpoint) and thereby reducing the amount of initial femoral stem migration occurring before osseointegration (secondary endpoint). We excluded females with Dorr C‐type femur morphology They have osteoporosis[31] and show an increased risk of periprosthetic fracture if treated with cementless total hip arthroplasty.[32]
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