ArticleJB & JS open access
Abaloparatide Increases Distal Femur Bone Mineral Density Post-Total Knee Arthroplasty.
Article in JB & JS open access. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04167163 (An Open-Label Phase 2 Study of Abaloparatide to Mitigate Distal Femoral Bone Loss Following Total Knee Arthroplasty), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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An Open-Label Phase 2 Study of Abaloparatide to Mitigate Distal Femoral Bone Loss Following Total Knee Arthroplasty
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Osteoporosis is common in joint replacement patients and increases adverse outcome risk. Data indicate that total knee arthroplasty (TKA) causes distal femur bone loss. We hypothesized that abaloparatide (ABL) would mitigate this loss. The study's purpose was to evaluate the effect of ABL initiated before TKA on distal femur bone mineral density (BMD) in osteoporotic patients. Methods: TKA candidates age ≥55 years were enrolled in this open-label, prospective, observational 18-month study. Those with clinical osteoporosis, defined as lowest Results: At screening (n = 58; 29 ABL/29 control) sex, mean age and mean BMI did not differ between groups. ABL group screening BMD was lower (p ≤ 0.05) at all sites except the L-spine. ABL was dosed for a mean (SD) of 96 (60) days before TKA. Control group distal femur BMD was statistically unchanged, -1.0% and -2.4% at the 15% and 25% ROIs, respectively, at 15 months post-TKA, (p ≥ 0.34). ABL group distal femur BMD increased at the 15% and 25% ROIs and differed from control by 4.6% to 7.6% (all p < 0.01) at 6 and 15 months post-TKA. Knee injury and Osteoarthritis Outcome Score for Joint Replacement demonstrated significantly worse (<0.05) function at baseline in the osteoporotic group and greater improvement over time compared with controls. Conclusion: ABL increases distal femur BMD in osteoporotic patients undergoing TKA. Unlike prior reports distal femur BMD did not decrease after TKA among controls; further study to clarify the effect of TKA on distal femur BMD is needed. Trial Registration: Clinical trial status-open-label prospective trial registered at ClinicalTrials.gov: NCT04167163. Level of Evidence: Level II, Therapeutic. See Instructions for Authors for a complete description of levels of evidence.
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