Real-world bone turnover marker use: impact on treatment decisions and fracture.

The use of bone turnover marker (BTM) testing for patients with osteoporosis in the USA has not been well characterized. This retrospective US-based real-world data study found BTM testing has some association with treatment decision-making and lower fracture risk in patients with presumed osteoporosis, supporting its use in clinical practice. INTRODUCTION: The purpose of this study was to characterize bone turnover marker (BTM) testing patterns and estimate their clinical utility in treatment decision-making and fragility fracture risk in patients with osteoporosis using a retrospective claims database. METHODS: Data from patients aged ≥ 50 years with newly diagnosed osteoporosis enrolled in the Truven MarketScan® Commercial Claims and Encounters and Medicare Supplemental and Co-ordination of Benefits databases from January 2008 to June 2018 were included. Osteoporosis was ascertained by explicit claims, fragility fracture events associated with osteoporosis, or prescribed anti-resorptive or anabolic therapy. BTM-tested patients were 1:1 propensity score matched to those untested following diagnosis. Generalized estimating equation models were performed to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for testing versus no testing on both treatment decision-making and fragility fracture. RESULTS: Of the 457,829 patients with osteoporosis, 6075 were identified with ≥ 1 BTM test following diagnosis; of these patients, 1345 had a unique treatment decision made ≤ 30 days from BTM testing. The percentage of patients receiving BTM tests increased significantly each year (average annual % change: + 8.1%; 95% CI: 5.6-9.0; p = 0.01). Patients tested were significantly more likely to have a treatment decision (OR: 1.14; 95% CI: 1.13-1.15), and testing was associated with lower odds of fracture versus those untested (OR: 0.87; 95% CI: 0.85-0.88). CONCLUSION: In this large, heterogeneous population of patients with presumed osteoporosis, BTM testing was associated with treatment decision-making, likely leading to fragility fracture reduction following use.

Production and analysis of specific monoclonal antibodies against the cell wall of Mycobacterium avium.

Monoclonal antibodies (mAbs) against Mycobacterium avium were produced which specifically reacted with cell walls of M. avium. The binding pattern was not limited to one subtype. The three most specific mAbs showed binding to the outer surface of M. avium but not to other mycobacterial or bacterial cell surfaces. The combined results of enzyme-linked immunosorbent assay, immunoblot and dot blot showed that mAb 4A006 bound to an epitope located in the cell wall and on the cell surface and mAb 4A010 to an epitope exposed on the cell surface and the cytoplasm. The mAb 4A009-binding epitope was only detectable on the cell surface but not in the cell wall or cytoplasmic fractions of M. avium. In the immunoblot technic a protein antigen with a molecular mass of 27-29 kDa was identified by the mAbs. The mAb 4A006 reacted with 142 out of 143 M. avium subtypes 1, 4 and 8 obtained from AIDS patients. These mAbs seem to be applicable for the identification of M. avium complex after culture.