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.

Precision of 3.0 Tesla quantitative magnetic resonance imaging of cartilage morphology in a multicentre clinical trial.

OBJECTIVE: Quantitative MRI (qMRI) of cartilage morphology is a promising tool for disease-modifying osteoarthritis drug (DMOAD) development. Recent studies at single sites have indicated that measurements at 3.0 Tesla (T) are more reproducible (precise) than those at 1.5 T. Precision errors and stability in multicentre studies with imaging equipment from various vendors have, however, not yet been evaluated. METHODS: A total of 158 female participants (97 Kellgren and Lawrence grade (KLG) 0, 31 KLG 2 and 30 KLG 3) were imaged at 7 clinical centres using Siemens Magnetom Trio and GE Signa Excite magnets. Double oblique coronal acquisitions were obtained at baseline and at 3 months, using water excitation spoiled gradient echo sequences (1.0x0.31x0.31 mm3 resolution). Segmentation of femorotibial cartilage morphology was performed using proprietary software (Chondrometrics GmbH, Ainring, Germany). RESULTS: The precision error (root mean square coefficient of variation (RMS CV)%) for cartilage thickness/volume measurements ranged from 2.1%/2.4% (medial tibia) to 2.9%/3.3% (lateral weight-bearing femoral condyle) across all participants. No significant differences in precision errors were observed between KLGs, imaging sites, or scanner manufacturers/types. Mean differences between baseline and 3 months ranged from <0.1% (non-significant) in the medial to 0.94% (p<0.01) in the lateral femorotibial compartment, and were 0.33% (p<0.02) for the total femorotibial subchondral bone area. CONCLUSIONS: qMRI performed at 3.0 T provides highly reproducible measurements of cartilage morphology in multicentre clinical trials with equipment from different vendors. The technology thus appears sufficiently robust to be recommended for large-scale multicentre trials.

Proximal femur: assessment for osteoporosis with T2* decay characteristics at MR imaging.

PURPOSE: To use T2* measurements at magnetic resonance (MR) imaging to investigate the trabecular structure of the hip in women with and women without osteoporotic hip fractures and to compare this technique with bone mineral density (BMD) measurements in the diagnosis of fractures. MATERIALS AND METHODS: T2* maps of the proximal femur were obtained at 1.5 T in 23 postmenopausal study patients with osteoporotic hip fractures, 27 age-matched healthy postmenopausal control subjects, and five healthy premenopausal control subjects. A modified gradient-recalled acquisition in the steady state, or GRASS, sequence was used with echo times of 4-40 msec at 4-msec increments. T2* values were measured in five regions of interest: femoral neck, the Ward triangle, trochanter, intertrochanteric region, and total proximal femur. Additionally, BMD measurements of the hip were obtained with dual x-ray absorptiometry. RESULTS: Significant differences between T2* measurements were obtained in all three groups (P < .05). BMD measurements of the hip also showed significant differences (P < .05). For T2* and BMD measurements, odds ratios and areas under the curve in receiver operating characteristic analysis were comparable. Correlations between 1/T2* values and BMD were significant (P < .05). T2* measurements in the proximal femur showed regional variations. CONCLUSION: MR imaging decay characteristics of bone marrow could be used to differentiate between postmenopausal women with and those without osteoporotic hip fractures.

Assessment of bone mineral at appendicular sites in females with fractures of the proximal femur.

The prediction of hip fractures by measurements at remote sites or the improvement of predictive power by measurements at multiple sites could potentially increase the success of osteoporosis screening programs. In a cross-sectional study on 137 postmenopausal women, we tested the hypothesis that bone assessment at the hip, the forearm, and the tibia are independently associated with osteoporotic fractures of the hip. Bone mineral densities, geometric features, and ultrasound properties were determined with hip dual X-ray absorptiometry, forearm peripheral quantitative computed tomography (QCT), and tibia speed of sound measurement. While the odds ratios for fracture discrimination per standard deviation decrease ranged between 3 and 4 for measurements at the hip, they were only 1.8 at the forearm and 1.4 at the tibia. Measurements at the tibia or the forearm were neither independently associated with osteoporotic hip fractures (p > 0.05) nor could any combination of measurements significantly increase the power for the identification of fractures as measured with receiver operating curves. Women who sustained trochanteric fractures were characterized by a generalized loss of bone mineral. Cervical fractures were associated with a decrease of bone mineral density at the hip, but no significant alterations in bone mass or geometric properties were observed at the tibia or at the forearm. Fracture risk prediction at the hip is therefore preferably performed by measurements at the hip itself. Peripheral QCT at the distal radius and tibial ultrasound seem capable of depicting women with an increased risk for trochanteric but not for cervical fractures. The risk assessment appears not to be improved by including information of cortical or geometric properties of the forearm.

Assessment of needle arthroscopy, standard arthroscopy, physical examination, and magnetic resonance imaging in knee pain: a pilot study.

Nine patients with mechanical or osteoarthritic knee pain present for more than 6 weeks were evaluated by clinical examination, needle arthroscopy, and standard arthroscopy. Each knee was assessed for patellofemoral cartilage disruption, cartilage abnormalities in the tibiofemoral joints, meniscal tears, and synovitis. Needle arthroscopy was performed immediately before standard arthroscopy in the operating room under local anesthesia. Six of the nine patients had magnetic resonance imaging (MRI) scans before the arthroscopic procedures. The clinical examination was 100% sensitive for the detection of patellofemoral disease, 62% sensitive for medial meniscal tears, and 14% sensitive for lateral meniscal tears. Visualization of the femoral-tibial joint was significantly better with standard arthroscopy than with needle arthroscopy (p = 0.002). Percent visualization with the needle arthroscope was higher for the patellofemoral and the medical tibiofemoral cartilage compared to the lateral tibiofemoral cartilage and menisci (p < 0.05). The needle arthroscope and MRI scan were equivalent to the standard arthroscope in the detection of patellofemoral cartilage disruption of any depth and in the detection of meniscal tears. However, the standard arthroscope was better in detecting cartilage abnormalities in the medial and lateral joint spaces (p < 0.05 and p < 0.01, respectively). The costs for diagnostic standard arthroscopy, needle arthroscopy, and MRI of the knee in an academic center are $3900, $1650, and $900, respectively. These data suggest that the majority of reversible causes of knee pain are diagnosed by physical examination. Therefore, after a complete history and physical examination, if the physician thinks that the patient has an internal derangement of the knee and that surgical intervention is needed, we suggest that the patient go directly to standard arthroscopy, which offers both confirmation and therapy. The MRI scan or needle arthroscopy should be considered only if, after a history and physical examination, the diagnosis of the knee pain is unclear.