Best Practice Guidelines for Assessment and Management of Osteoporosis in Adult Patients Undergoing Elective Spinal Reconstruction.

STUDY DESIGN: Expert consensus study. OBJECTIVE: This expert panel was created to establish best practice guidelines to identify and treat patients with poor bone health prior to elective spinal reconstruction. SUMMARY OF BACKGROUND DATA: Currently, no guidelines exist for the management of osteoporosis and osteopenia in patients undergoing spinal reconstructive surgery. Untreated osteoporosis in spine reconstruction surgery is associated with higher complications and worse outcomes. METHODS: A multidisciplinary panel with 18 experts was assembled including orthopedic and neurological surgeons, endocrinologists, and rheumatologists. Surveys and discussions regarding the current literature were held according to Delphi method until a final set of guidelines was created with over 70% consensus. RESULTS: Panelists agreed that bone health should be considered in every patient prior to elective spinal reconstruction. All patients above 65 and those under 65 with particular risk factors (chronic glucocorticoid use, high fracture risk or previous fracture, limited mobility, and eight other key factors) should have a formal bone health evaluation prior to undergoing surgery. DXA scans of the hip are preferable due to their wide availability. Opportunistic CT Hounsfield Units of the vertebrae can be useful in identifying poor bone health. In the absence of contraindications, anabolic agents are considered first line therapy due to their bone building properties as compared with antiresorptive medications. Medications should be administered preoperatively for at least 2 months and postoperatively for minimum 8 months. CONCLUSION: Based on the consensus of a multidisciplinary panel of experts, we propose best practice guidelines for assessment and treatment of poor bone health prior to elective spinal reconstructive surgery. Patients above age 65 and those with particular risk factors under 65 should undergo formal bone health evaluation. We also established guidelines on perioperative optimization, utility of various diagnostic modalities, and the optimal medical management of bone health in this population.Level of Evidence: 5.

Use of Bone Health Evaluation in Orthopedic Surgery: 2019 ISCD Official Position.

This position development conference (PDC) Task Force examined the assessment of bone status in orthopedic surgery patients. Key questions included which orthopedic surgery patients should be evaluated for poor bone health prior to surgery and which subsets of patients are at high risk for poor bone health and adverse outcomes. Second, the reliability and validity of using bone densitometry techniques and measurement of specific geometries around the hip and knee before and after arthroplasty was determined. Finally, the use of computed tomography (CT) attenuation coefficients (Hounsfield units) to estimate bone quality at anatomic locations where orthopedic surgery is performed including femur, tibia, shoulder, wrist, and ankle were reviewed. The literature review identified 665 articles of which 198 met inclusion exclusion criteria and were selected based on reporting of methodology, reliability, or validity results. We recommend that the orthopedic surgeon be aware of established ISCD guidelines for determining who should have additional screening for osteoporosis. Patients with inflammatory arthritis, chronic corticosteroid use, chronic renal disease, and those with history of fracture after age 50 are at high risk of osteoporosis and adverse events from surgery and should have dual energy X-ray absorptiometry (DXA) screening before surgery. In addition to standard DXA, bone mineral density (BMD) measurement along the femur and proximal tibia is reliable and valid around implants and can provide valuable information regarding bone remodeling and identification of loosening. Attention to positioning, selection of regions of interest, and use of special techniques and software is required. Plain radiographs and CT provide simple, reliable methods to classify the shape of the proximal femur and to predict osteoporosis; these include the Dorr Classification, Cortical Index, and critical thickness. Correlation of these indices to central BMD is moderate to good. Many patients undergoing orthopedic surgery have had preoperative CT which can be utilized to assess regional quality of bone. The simplest method available on most picture archiving and communications systems is to simply measure a regions of interest and determine the mean Hounsfield units. This method has excellent reliability throughout the skeleton and has moderate correlation to DXA based on BMD. The prediction of outcome and correlation to mechanical strength of fixation of a screw or implant is unknown.

Trabecular Bone Score in Patients With Chronic Glucocorticoid Therapy-Induced Osteoporosis Treated With Alendronate or Teriparatide.

OBJECTIVE: To determine the effect of alendronate (ALN) and teriparatide on trabecular bone score (TBS) in patients with glucocorticoid-induced osteoporosis. METHODS: Patients with chronic glucocorticoid therapy-induced osteoporosis (median 7.5 mg/day prednisone equivalent for ≥90 days) were randomized to receive oral ALN 10 mg/day (n = 214) or subcutaneous teriparatide 20 µg/day (n = 214) for 36 months; 118 patients in the ALN group and 123 patients in the teriparatide group completed treatment. Dual x-ray absorptiometry (DXA) results for 53 patients receiving ALN and 56 patients receiving teriparatide who had DXA scans with adequate resolution to perform TBS analysis and completed 36 months of therapy were blindly analyzed for TBS at baseline and 3, 6, 12, 18, 24, and 36 months. RESULTS: In teriparatide-treated patients, TBS was significantly increased at 18 months compared to baseline, and by 36 months had increased 3.7% (P < 0.05). In ALN-treated patients, there was not a significant change in TBS compared to baseline at any time point. Changes in lumbar spine bone mineral density (BMD) measured by DXA in the subgroup with TBS data were similar to BMD results in the overall study population. At 36 months, increases in lumbar spine BMD were 5.5% and 10.3% in patients treated with ALN and teriparatide, respectively. CONCLUSION: In patients with glucocorticoid-induced osteoporosis, both ALN and teriparatide increased lumbar spine BMD. However, trabecular bone score significantly increased with teriparatide but did not significantly change with ALN. The pathogenesis of glucocorticoid-induced osteoporosis is predominantly reduced bone formation. TBS may represent a sensitive measure to discriminate treatment effects of an anabolic versus an antiresorptive drug in glucocorticoid-induced osteoporosis.

Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial.

BACKGROUND: There is a medical need for therapies that improve hip fracture healing. Teriparatide (Forteo(®)/ Forsteo(®), recombinant human parathyroid hormone) is a bone anabolic drug that is approved for treatment of osteoporosis and glucocorticoid-induced osteoporosis in men and postmenopausal women at high fracture risk. Preclinical and preliminary clinical data also suggest that teriparatide may enhance bone healing. QUESTIONS/PURPOSES: We wished to test the hypotheses that treatment with teriparatide versus placebo would improve femoral neck fracture healing after internal fixation as measured by (1) frequency of revision surgery, (2) radiographic fracture healing, and (3) other outcomes including pain control, gait speed, and safety. METHODS: We initiated two separate, but identically designed, clinical trials to meet FDA requirements to provide substantial evidence to support approval of a new indication. The two prospective, randomized double-blind, placebo-controlled Phase III studies were designed to evaluate the effect of subcutaneous teriparatide (20 µg/day) for 6 months versus placebo on fracture healing at 24 months. The trials were conducted concurrently with a planned enrollment of 1220 patients per trial. However, enrollment was stopped owing to very slow patient accrual, and an a priori decision was made to pool the results of those studies for statistical analyses before study completion; pooling was specified in both protocols. Randomization was stratified by fixation (sliding hip screw or multiple cancellous screws) and fracture type (displaced or nondisplaced). An independent Central Adjudication Committee reviewed revision surgical procedures and radiographs. A total of 159 patients were randomized in the two trials (81 placebo, 78 teriparatide). The combined program had very low power to detect the originally expected treatment effect but had approximately 80% power to detect a larger difference of 12% between treatment groups for risk of revision surgery. RESULTS: The proportion of patients undergoing revision surgery at 12 months was 14% (11 of 81) in the placebo group versus 17% (13 of 78) in the teriparatide group. Central Adjudication Committee review excluded two of these patients treated with placebo from the primary analysis. After exclusions, the proportion of patients who did not undergo revision surgery at 12 months (primary endpoint) was not different between the study and placebo groups, at 88% in the placebo group (90% CI, 0.79-0.93) versus 84% in the teriparatide group (90% CI, 0.75-0.90; p = 0.743). There also were no differences between groups in the proportion of patients achieving radiographic fracture healing at 12 months (75% [61 of 81] placebo versus 73% [57 of 78] teriparatide; odds ratio, 0.89; 90% CI, 0.46-1.72; p = 0.692) or in measures of pain control (such as pain during ambulation, 92% [55 of 62] placebo versus 91% [52 of 57] teriparatide; odds ratio, 0.91; 90% CI, 0.25-3.37; p = 0.681). The frequency of patients reporting adverse events was 49% [40 of 81] in the placebo group versus 45% [35 of 78] in the teriparatide group (p = 0.634) during the 6-month treatment period. CONCLUSIONS: The small sample size limited this study's power to detect potential differences, and the results are exploratory. With the patients available, teriparatide did not decrease the risk of revision surgery, improve radiographic signs of fracture healing, or decrease pain compared with the placebo. The adverse event data observed were consistent with the teriparatide safety profile. Functional and health outcome data from the studies may help improve our understanding of patients recovering from femoral neck fractures. Further large controlled studies are required to determine the effect of teriparatide on fracture healing. LEVEL OF EVIDENCE: Level II, prospective study.

Osteoporosis medication use after hip fracture in U.S. patients between 2002 and 2011.

Hip fractures are common, morbid, costly, and associated with subsequent fractures. Historically, postfracture osteoporosis medication use rates have been poor, but have not been recently examined in a large-scale study. We conducted a retrospective, observational cohort study based on U.S. administrative insurance claims data for beneficiaries with commercial or Medicare supplemental health insurance. Eligible participants were hospitalized for hip fracture between January 1, 2002, and December 31, 2011, and aged 50 years or older at admission. The outcome of interest was osteoporosis medication use within 12 months after discharge. Patients were censored after 12 months, loss to follow-up, or a medical claim for cancer or Paget's disease, whichever event occurred first. During the study period, 96,887 beneficiaries met the inclusion criteria; they had a mean age of 80 years and 70% were female. A total of 34,389 (35.5%) patients were censored before reaching 12 months of follow-up. The Kaplan-Meier estimated probability of osteoporosis medication use within 12 months after discharge was 28.5%. The rates declined significantly from 40.2% in 2002, to 20.5% in 2011 (p for trend <0.001). In multivariable Cox proportional hazards models, a number of patient characteristics were associated with reduced likelihood of osteoporosis medication use, including older age and male gender. However, the predictor most strongly and most positively associated with osteoporosis medication use after fracture was osteoporosis medication use before the fracture (hazard ratio = 7.45; 95% confidence interval [CI], 7.23-7.69). Most patients suffering a hip fracture do not use osteoporosis medication in the subsequent year and treatment rates have worsened.

Hip and spine strength effects of adding versus switching to teriparatide in postmenopausal women with osteoporosis treated with prior alendronate or raloxifene.

Many postmenopausal women treated with teriparatide for osteoporosis have previously received antiresorptive therapy. In women treated with alendronate (ALN) or raloxifene (RLX), adding versus switching to teriparatide produced different responses in areal bone mineral density (aBMD) and biochemistry; the effects of these approaches on volumetric BMD (vBMD) and bone strength are unknown. In this study, postmenopausal women with osteoporosis receiving ALN 70 mg/week (n = 91) or RLX 60 mg/day (n = 77) for ≥18 months were randomly assigned to add or switch to teriparatide 20 µg/day. Quantitative computed tomography scans were performed at baseline, 6 months, and 18 months to assess changes in vBMD; strength was estimated by nonlinear finite element analysis. A statistical plan specifying analyses was approved before assessments were completed. At the spine, median vBMD and strength increased from baseline in all groups (13.2% to 17.5%, p < 0.01); there were no significant differences between the Add and Switch groups. In the RLX stratum, hip vBMD and strength increased at 6 and 18 months in the Add group but only at 18 months in the Switch group (Strength, Month 18: 2.7% Add group, p < 0.01 and 3.4% Switch group, p < 0.05). In the ALN stratum, hip vBMD increased in the Add but not in the Switch group (0.9% versus -0.5% at 6 months and 2.2% versus 0.0% at 18 months, both p ≤ 0.004 group difference). At 18 months, hip strength increased in the Add group (2.7%, p < 0.01) but not in the Switch group (0%); however, the difference between groups was not significant (p = 0.076). Adding or switching to teriparatide conferred similar benefits on spine strength in postmenopausal women with osteoporosis pretreated with ALN or RLX. Increases in hip strength were more variable. In RLX-treated women, strength increased more quickly in the Add group; in ALN-treated women, a significant increase in strength compared with baseline was seen only in the Add group.

Factors Associated with Persistence with Teriparatide Therapy: Results from the DANCE Observational Study.

Purpose. Determine patient-reported reasons for discontinuation with teriparatide. Methods. Patients taking teriparatide in a multicenter, prospective, and observational study were given three questionnaires: baseline, follow-up questionnaire 1 (QF1, 2 to 6 months), and follow-up questionnaire 2 (QF2, 12 months). Discontinuation reported at QF1 and QF2 was defined as "early" and "late," respectively, and remaining patients were considered persistent. Cochran-Armitage trend test was used to identify factors associated with discontinuation. Results. Side effects, concern about improper use, injection difficulties, and several patient-perceived physician issues were associated with early discontinuation. Low patient-perceived importance of continuing treatment, side effects, difficulty paying, and low patient-perceived physician knowledge were associated with late discontinuation. The most common specific reasons selected for discontinuing treatment were "concerns about treatment outweighing the benefits" (n = 53) and "difficulty paying" (n = 47). Conclusions. Persistence with teriparatide is dependent on managing side effects, addressing financial challenges, proper training, and obtaining support from the healthcare provider.

Risk factors for osteoporosis in Alaska Native women: a cross-sectional survey.

OBJECTIVES: To estimate the prevalence of risk factors for osteoporosis in Alaska Native (AN) women and to assess the feasibility of portable bone density measurement in rural Alaska. METHODS: We conducted a cross-sectional survey of a convenience sample of 452 patients from 17 clinics in Alaska. We interviewed subjects regarding risk factors for osteoporosis and measured calcaneal bone density by ultrasound. RESULTS: Of the 452 women, 316 (70%) were Alaska Natives. Risk factors for osteoporosis were common among study participants. Total dietary calcium intake was low (mean = 306 mg/day). Current smokers [Odds Ratio (OR) = 3.9, 95% Confidence Interval (95% C.I.) 1.8, 8.4], former smokers (OR = 2.8, 95% C.I. 1.3, 6.2) and chronic users of oral steroids (OR = 4.7, 95% C.I. 1.8, 12.0) were at increased risk for low bone density. CONCLUSIONS: Reduction of cigarette smoking, increase in dietary calcium, and reduction of oral steroid use would likely decrease the prevalence of osteoporosis in AN women. A comprehensive prevention program including bone density screening is warranted in rural Alaska.