The investigator hypothesizes that treating osteoporotic patients with abaloparatide prior to and after total knee arthroplasty will significantly reduce the amount of bone loss.
In primary unilateral total knee arthroplasty patients, The investigator will examine the effect of daily abaloparatide therapy in clinical osteoporotic patients beginning 3 months pre-op and continued for a total of 15 months. This will be compared to osteopenic patients receiving no therapy as well as previously published values in untreated osteoporotic patients 12 months following Total Knee Arthroplasty (TKA).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
18 month ABL treatment
University of Wisconsin
Madison, Wisconsin, United States
Change in Distal Femoral Bone Mineral Density (BMD) at the 25% Regions of Interest (ROIs)
Bone mineral density change at the 25% ROI of the surgical leg. Dual-energy X-ray absorptiometry (DXA) measured BMD was obtained at a point (ROI) 25% the length of the total surgical femur. Percent change at 25% ROI was calculated from baseline to 18 months.
Time frame: Baseline and approximately 18 months on study (15 months post-TKA)
Change in Distal Femoral BMD at the 15% and 60% ROI
Bone mineral density percent change at the 15% and 60% ROI of the surgical leg
Time frame: Baseline and approximately 18 months on study (15 months post-TKA)
TBS Assessment by TRIP at the 15%, 25%, and 60% Femur ROIs
Trabecular bone score (TBS) assessment by Texture Research Investigation (Platform (TRIP) software change at the 15% and 25% femur ROIs (TBS \>1.350 is normal; TBS between 1.200 and 1.350 is indicative of partially degraded microarchitecture; and TBS \<1.200 equals degraded microarchitecture).
Time frame: 18 months on study (15 months post-TKA)
Knee Injury & Osteoarthritis Outcome Score (KOOS) JR
Patient reported knee function score. The KOOS, JR was developed from the original long version of the Knee injury and Osteoarthritis Outcome Score (KOOS) survey using Rasch analysis. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score (0-100). The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Time frame: 18 months on study (15 months post-TKA)
Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Physical Health Component
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12 Item Health Survey using patient's self assessment of their perspective of their health and ability to do daily functions. Scores are derived using an algorithm that is referenced to a metric centered at 50.0 where a zero score indicates the lowest level of health and 100 indicates the highest level of health.
Time frame: Baseline and approximately 18 months on study (15 months post-TKA)
Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Mental Health Component
12 Item Health Survey using patient's self assessment of their perspective of their health and ability to do daily functions. Scores are derived using an algorithm that is referenced to a metric centered at 50.0 where a zero score indicates the lowest level of health and 100 indicates the highest level of health.
Time frame: Baseline and approximately 18 months on study (15 months post-TKA)
Forgotten Joint Survey(FJS) Score
FJS-12 consists of 12 questions and is scored using a 5-point response format with the raw scores transformed onto a 0- to 100-point scale. High scores indicate good outcome, that is, a high degree of forgetting the joint in everyday life (forgotten joint phenomenon).
Time frame: 18 months on study (15 months post-TKA)
Change in Body Composition Using Bioelectrical Impedance Analysis of Lean Mass
Change in total body composition using bioelectrical impedance analysis of lean mass.
Time frame: Baseline and approximately 18 months on study (15 months post-TKA)
Change in Body Composition Using Bioelectrical Impedance Analysis of Fat Mass.
Change in total body composition using bioelectrical impedance analysis of fat mass.
Time frame: Baseline and approximately 18 months on study (15 months post-TKA)
TKA Complications: Number of Participants Needed Revision Surgery
TKA complications: Number of participants needed revision surgery
Time frame: 18 months on study (15 months post-TKA)
TKA Complications: Number of Participants Had Fracture
TKA complications: Number of participants had fracture
Time frame: 18 months on study (15 months post-TKA)
Precision Error on Knee Bone Density Measurement
Precision assessment in the field of bone densitometry is the process whereby the ability of the instrument and the technologist to reproduce similar results, given no real biologic change, is tested. To achieve statistical power, the investigators will take duplicate knee bone density measurements on 30 participants at either their 6 month or 15 month visit. The standard deviation for each participant is calculated, then the root mean square standard deviation for the group is calculated. The mathematical result of precision assessment is displayed as percent coefficient of variation (CV).
Time frame: 18 months on study (15 months post-TKA)