Abaloparatide Before Total Knee Arthroplasty
- Conditions
- Arthroplasties, Knee ReplacementOsteoporosis
- Interventions
- Registration Number
- NCT04167163
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
The investigator hypothesizes that treating osteoporotic patients with abaloparatide prior to and after total knee arthroplasty will significantly reduce the amount of bone loss.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group Abaloparatide Those with clinical osteoporosis who elect ABL treatment. ABL therapy will begin 3 months pre-TKA and continue for a total of 18 months. ABL will be administered by injection pen with dose of 80 mcg SC qDay.
- Primary Outcome Measures
Name Time Method Change in Distal femoral Bone mineral density (BMD) at the 25% regions of interest (ROIs) Baseline and 18 months Bone mineral density change at the 25% ROI of the surgical leg
- Secondary Outcome Measures
Name Time Method Change in Veterans RAND 12 (VR-12) Question Health Survey score Baseline and 18 months 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.
Forgotten Joint Survey(FJS) score 18 months 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).Change in body composition using bioelectrical impedance analysis of lean mass Baseline and 18 months Change in body composition using bioelectrical impedance analysis of lean mass.
Change in Distal femoral BMD at the 15% and 60 %ROI Baseline and 18 months Bone mineral density change at the 15% and 60% ROI of the surgical leg
Change in Femur cortical thickness at the 15%, 25% and 60% femur ROIs Baseline and 18 months Cortical thickness change at the 15% and 60% ROI of the surgical leg
Knee injury & Osteoarthritis Outcome Score (KOOS) JR 18 months 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.
TKA complications: Number of participants needed revision surgery 18 months TKA complications: Number of participants needed revision surgery
TBS assessment by TRIP at the 15%, 25% and 60% femur ROIs 18 months Trabecular bone score (TBS) assessment by Texture Research Investigation (Platform (TRIP) software change at the 15%, 25% and 60% 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)
Change in body composition using bioelectrical impedance analysis of fat mass. Baseline and 18 months Change in body composition using bioelectrical impedance analysis of fat mass.
Change in body composition using bioelectrical impedance analysis of skeletal mass. Baseline and 18 months Change in body composition using bioelectrical impedance analysis of skeletal mass.
TKA complications: Number of participants had fracture 18 months TKA complications: Number of participants had fracture
Precision Error on Knee Bone Density Measurement up to 15 months 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. The mathematical result of precision assessment is called the precision error. 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.
Trial Locations
- Locations (1)
University of Wisconsin
🇺🇸Madison, Wisconsin, United States