Response rates for lumbar spine, total hip, and femoral neck bone mineral density in men treated with abaloparatide: results from the ATOM study.

Osteoporosis in men is an underappreciated public health issue, accounting for approximately 30% of the societal burden of osteoporosis. Although the prevalence of osteoporosis in men is lower, fracture-related morbidity and mortality rates exceed those of women. Abaloparatide is a synthetic, 34-amino acid peptide with homology to human parathyroid hormone-related protein (PTHrP), which favors bone formation by selective activation of PTH receptor type 1. In the Abaloparatide for the Treatment of Men With Osteoporosis (ATOM; NCT03512262) trial, 228 men with primary or hypogonadism-associated osteoporosis were randomized to receive subcutaneous injections of abaloparatide 80 µg or placebo. Abaloparatide significantly improved LS, TH, and FN BMD when compared with placebo. In this prespecified analysis, the proportion of men with a percent change from baseline of >0%, >3%, and > 6% in BMD at the LS, TH, and FN at 3, 6, and 12 mo and/or a shift in T-score category (based on LS and TH T-scores) at 12 mo was compared between the abaloparatide and placebo groups in ATOM. There were significantly more men with a BMD gain of >3% at all 3 anatomical sites in the abaloparatide than placebo group at month 6 (18/122 [14.8%] vs 1/70 [1.4%], P = .002) and at month 12 (38/119 [31.9%] vs 1/66 [1.5%], P < .0001). At month 3, more men treated with abaloparatide than placebo had a > 3% BMD increase at the LS (82/134 [61.2%] vs 21/68 [30.9%], P < .0001). A greater proportion of men treated with abaloparatide had an improvement in T-score category from osteoporosis to low BMD or normal when compared with placebo. In conclusion, use of abaloparatide compared with placebo for 12 mo resulted in significant and rapid improvements in BMD in men with osteoporosis from the ATOM study.

Comparison of the cost-effectiveness of sequential treatment with abaloparatide in US men and women at very high risk of fractures.

BACKGROUND: Osteoporotic-related fractures represent an increasing burden to patients, health care systems and society. AIMS: This study estimated cost-effectiveness of sequential treatment with abaloparatide (ABL) followed by alendronate (ALN) compared to relevant alternative strategies in US men and women aged 50 to 80 years at very high fracture risk (bone mineral density T-score ≤ - 2.5 and a recent fracture). METHODS: A lifetime Markov-based microsimulation model was used to estimate healthcare costs and quality-adjusted life years (QALYs). Comparators were sequential treatment with unbranded teriparatide (TPTD)/ALN, generic ALN monotherapy, and no treatment. Analyses were conducted based on initial fracture site (hip, vertebral, or any fracture) and treatment efficacy data (derived from clinical trials or a recent network meta-analysis). RESULTS: From all analyses completed, sequential ABL/ALN demonstrated more QALYs for lower healthcare costs versus unbranded TPTD/ALN. No treatment was dominated (higher costs for less QALYs) versus ALN monotherapy. Sequential ABL/ALN resulted in favorable cost-effectiveness (at US threshold of $150,000/QALY) versus generic ALN monotherapy in men aged ≥ 50 years with any fracture type, women aged ≥ 65 years with any fracture type, and women aged ≥ 55 years having a hip or vertebral fracture. DISCUSSION: Similar cost-effectiveness of sequential ABL/ALN versus unbranded TPTD/ALN, ALN monotherapy, and no treatment was observed in both US men and women at very high fracture risk, with a moderate improvement in cost-effectiveness in men versus women and in patients with a hip or vertebral fracture. CONCLUSIONS: Sequential therapy with ABL/ALN was cost-effective in US men and women at very high risk of fractures.

Cost-Effectiveness of Sequential Abaloparatide/Alendronate in Men at High Risk of Fractures in the United States.

BACKGROUND AND OBJECTIVES: Abaloparatide (ABL) significantly increases bone mineral density in men with osteoporosis similar to what was reported in postmenopausal women with osteoporosis. The cost effectiveness of sequential treatment with ABL followed by alendronate (ALN) in men at high fracture risk was compared to relevant alternative treatments. METHODS: A Markov-based microsimulation model based on a lifetime US healthcare decision maker perspective was developed to evaluate the cost (expressed in US$2021) per quality-adjusted life-years (QALYs) gained of sequential ABL/ALN. Comparators were sequential treatment unbranded teriparatide (TPTD)/ALN, generic ALN monotherapy, and no treatment. Discount rates of 3% were used. Consistent with practice guidelines, patients received 18 months of ABL or TPTD followed by ALN for 5 years, or 5 years of ALN monotherapy. Analyses were conducted in high-risk men aged over 50 years defined as having a bone mineral density T-score ≤-2.5 and a recent fracture. Time-specific risk of subsequent fracture after a recent fracture, incremental costs up to 5 years following fractures, real-world medication adherence, and mostly US men-specific data were included in the model. One-way and probabilistic sensitivity analyses were conducted to assess the robustness of results. RESULTS: Over the full age range, sequential ABL/ALN led to more QALYs for lower costs than sequential unbranded TPTD/ALN, while no treatment was dominated (more QALYs, lower costs) by ALN monotherapy. The costs per QALY gained of sequential ABL/ALN were lower than the US threshold of US$150,000 versus generic ALN monotherapy. The probabilities that sequential ABL/ALN was cost effective compared to ALN monotherapy were estimated at 51% in men aged 50 years and between 88 and 90% in those aged ≥ 60 years. CONCLUSIONS: Sequential therapy using ABL/ALN may be cost effective compared with generic ALN monotherapy in US men aged ≥ 50 years at high fracture risk, especially in those aged ≥ 60 years. Unbranded TPTD/ALN and no treatment were dominated interventions (less QALY, more costs) compared with ABL/ALN or ALN monotherapy.

Cost Effectiveness Analyses of Interventions for Osteoporosis in Men: A Systematic Literature Review.

BACKGROUND: Osteoporosis is often considered to be a disease of women. Over the last few years, owing to the increasing clinical and economic burden, the awareness and imperative for identifying and managing osteoporosis in men have increased substantially. With the approval of agents to treat men with osteoporosis, more economic evaluations have been conducted to assess the potential economic benefits of these interventions. Despite this concern, there is no specific overview of cost-effectiveness analyses for the treatment of osteoporosis in men. OBJECTIVES: This study aims (1) to systematically review economic evaluations of interventions for osteoporosis in men; (2) to critically appraise the quality of included studies and the source of model input data; and (3) to investigate the comparability of results for studies including both men and women. METHODS: A literature search mainly using MEDLINE (via Ovid) and Embase databases was undertaken to identify original articles published between 1 January, 2000 and 30 June, 2022. Studies that assessed the cost effectiveness of interventions for osteoporosis in men were included. The Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases and the International Osteoporosis Foundation osteoporosis-specific guideline was used to assess the quality of design, conduct, and reporting of included studies. RESULTS: Of 2973 articles identified, 25 studies fulfilled the inclusion criteria, classified into economic evaluations of active drugs (n = 8) or nutritional supplements (n = 4), intervention thresholds (n = 5), screening strategies (n = 6), and post-fracture care programs (n = 2). Most studies were conducted in European countries (n = 15), followed by North America (n = 9). Bisphosphonates (namely alendronate) and nutritional supplements were shown to be generally cost effective compared with no treatment in men over 60 years of age with osteoporosis or prior fractures. Two other studies suggested that denosumab was cost effective in men aged 75 years and older with osteoporosis compared with bisphosphates and teriparatide. Intervention thresholds at which bisphosphonates were found to be cost effective varied among studies with a 10-year probability of a major osteoporotic fracture that ranged from 8.9 to 34.2% for different age categories. A few studies suggested cost effectiveness of screening strategies and post-fracture care programs in men. Similar findings regarding the cost effectiveness of drugs and intervention thresholds in women and men were captured, with slightly greater incremental cost-effectiveness ratios in men. The quality of the studies included had an average score of 18.8 out of 25 (range 13-23.5). Hip fracture incidence and mortality risk were mainly derived from studies in men, while fracture cost, treatment efficacy, and disutility were commonly derived from studies in women or studies combining both sexes. CONCLUSIONS: Anti-osteoporosis drugs and nutritional supplements are generally cost effective in men with osteoporosis. Screening strategies and post-fracture care programs also showed economic benefits for men. Cost-effectiveness and intervention thresholds were generally similar in studies conducted in both men and women, with slightly greater incremental cost-effectiveness ratios in men.

An Evaluation of Treatment Patterns for Osteoporosis and Outcomes After a Fragility Fracture in a Real-World Setting.

OBJECTIVES: Treatment initiation and persistence after a fragility fracture are critical to reduce the risk of subsequent fractures. The authors evaluated osteoporosis management and outcomes after index fracture. METHODS: This retrospective cohort study used real-world data for patients (≥50 years), including pharmacy claims linked to commercial and Medicare medical claims from Symphony Health Patient Source. Osteoporosis management was evaluated for at least 12 months after the first case-qualifying fracture during the identification period and continued until a second fracture or March 31, 2020 (depending on data availability). Secondary fracture incidence was evaluated overall and for subgroups at very high risk. RESULTS: Of 755,312 eligible patients, the proportion with a claim for bone mineral density testing at 12 months after index fracture was low [64,932 (8.6%)], and 75.3% of those tested were ≥65 years of age. Most patients (88.6%) remained untreated at any time after fracture. Among those treated, most (64.9%) were initially treated with bisphosphonates (oral, 93.7%; IV, 6.3%). Treatment duration and persistence were low for all treatments ranging from 6.5 months with 19.6% persistent for abaloparatide to 11.3 months with 45.0% persistent for denosumab. During follow-up, 13.6% of patients had a secondary fracture at any site, with higher incidence in subgroups considered to be at high risk for fracture than in the overall population. CONCLUSIONS: Low rates of osteoporosis testing and treatment initiation and high secondary fracture rates (particularly among patients at very high risk) highlight the need for better management of patients after a fracture. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Closing the gap in osteoporosis management: the critical role of primary care in bone health.

OBJECTIVE: The World Health Organization issued a call to action for primary care to lead efforts in managing noncommunicable diseases, including osteoporosis. Although common, osteoporosis remains underdiagnosed and undertreated. Primary care practitioners (PCPs) are critical in identifying individuals at risk for osteoporosis and osteoporotic fractures; however, recent advances in assessment, diagnosis, and treatment of osteoporosis have not been incorporated into clinical practice in primary care due to numerous reasons including time constraints and insufficient knowledge. To close this gap in clinical practice, we believe PCPs need a practical strategy to facilitate osteoporosis assessment and management that is easy to implement. METHODS: In this article, we consolidate information from various global guidelines and highlight areas of agreement to create a streamlined osteoporosis management strategy for a global audience of PCPs. RESULTS: We present a systematic approach to facilitate osteoporosis assessment and management that includes four steps: (1) identifying patients at risk through proactive screening strategies, (2) investigating and diagnosing patients, (3) intervening with personalized treatment plans, and (4) implementing patient-centered strategies for long-term management and monitoring of patients. CONCLUSION: Primary care has a central role in ensuring the incorporation of key elements of holistic care as outlined by the World Health Organization in managing noncommunicable diseases including osteoporosis; namely, a people-centered approach, incorporation of specialist services, and multidisciplinary care. This approach is designed to strengthen the health system's response to the growing osteoporosis epidemic.

Osteoporosis is a chronic condition associated with aging in which bones become "porous" and weak, and are more likely to break (i.e., fracture) even with minimal trauma such as tripping or falling from a standing height. A broken bone is a serious condition that not only affects daily activities, but can also lead to reduced quality of life, need for caregiver support, work loss, hospital and rehabilitation costs, nursing home costs, and increased mortality. Although osteoporosis is common, it is often undiagnosed or untreated, leaving many people at risk for experiencing broken bones. A broken bone increases the risk of more broken bones. Given the growing size of the aging global population, osteoporosis and the risk of broken bones represent an urgent problem and growing burden. We need ways to make it easier for primary care practitioners (PCPs), such as family physicians, internists, physician assistants, nurse practitioners, and nurses, to include osteoporosis care as part of routine clinical visits. In this article, we discuss the critical role of PCPs in early detection, diagnosis, and treatment of osteoporosis as they are often the first point of contact for at-risk patients. We present a simple, four-step approach to help PCPs and patients navigate the journey from osteoporosis diagnosis to a treatment plan. The four steps are to: (1) identify at-risk patients by screening for weak bones or osteoporosis, (2) perform necessary tests to diagnose patients, (3) develop a personalized treatment plan, and (4) determine long-term strategies for managing and monitoring bone health.

Understanding Attitudes, Beliefs, and Behaviors Surrounding Menopause Transition: Results from Three Surveys.

Purpose: To understand women's perspectives, attitudes, and beliefs surrounding menopause transition and increase understanding of digital technology use for symptom management. Patients and Methods: Information was obtained using three studies of women aged 40-65 years experiencing menopause transition symptoms. The HealthyWomen online cross-sectional survey was designed to reflect an inclusive sociodemographic sample representative of the US population. BECOME was a blinded, ethnographic, qualitative research study of women's menopause transition experiences and comprised facilitator-led online asynchronous discussions, online homework entries, and audio-only teleconferences. The NODE.Health online, two-part, cross-sectional patient survey was designed to capture patient and healthcare provider (HCP) sentiment about the use of digital health technologies to address gaps in perimenopausal symptom knowledge and management. Results: The HealthyWomen survey included 1045 participants, 37 were included in BECOME, and 100 completed the NODE.Health survey. Hot flashes, night sweats, and sleep problems were the most frequently experienced symptoms in the HealthyWomen survey, and over half of participants experiencing symptoms felt the need to seek relief. Whether menopause was considered a medical problem or natural process differed by self-identified race, culture, and ethnicity, as did the likelihood of consulting a HCP over symptoms. Participants preferred to discuss menopause transition with HCPs who did not rush them, were good listeners, and had expertise in the area. Most technology experience was with health websites, but nearly half were unsatisfied with online resources describing menopause-related symptoms. Convenience, ease of use, and accessibility were the most common reasons for pursuing digital health technology. Conclusion: Factors such as cultural beliefs, values and attitudes towards menopause determine personal experiences. More open discussions with friends, family, and HCPs may raise awareness and reduce barriers to seeking help. To provide optimal care throughout the menopause transition, HCPs should consider patients' psychosocial and cultural backgrounds, and personal and subjective perspectives.

Multidisciplinary Management of Menopause: Symposium Proceedings.

This proceeding summarizes a symposium on multidisciplinary management of menopause held on July 30, 2021 as part of the Health of Women 2021 conference. The workshop featured presentations by national experts who provided insights into multidisciplinary approaches to the management of menopause, vasomotor symptoms and genitourinary syndrome of menopause, bone health (including osteoporosis, muscular strength, and mobility), as well as sexual and psychological health during menopause. In this study, we highlight the major points of each presentation and the resultant discussion.

Cost-effectiveness of secondary fracture prevention intervention for Medicare beneficiaries.

BACKGROUND: Secondary fracture prevention intervention such as fracture liaison services are effective for increasing osteoporosis treatment rates, but are not currently widely used in the United States. We evaluated the cost-effectiveness of secondary fracture prevention intervention after osteoporotic fracture for Medicare beneficiaries. METHODS: An individual-level state-transition microsimulation model was developed to evaluate the cost-effectiveness of secondary fracture prevention intervention compared with usual care for U.S. Medicare patients aged 65 and older who experience a new osteoporotic fracture. Patients who initiated pharmacotherapy and remained adherent were assumed to be treated for 5 years. Outcome measures included subsequent fractures, average lifetime costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios in 2020 U.S. dollars per QALY gained. The model time horizon was lifetime, and analysis perspective was payer. RESULTS: Base-case analysis results showed that the secondary fracture prevention intervention strategy was both more effective and less expensive than usual care-thus, it was cost-saving. Model findings indicated that the intervention would reduce the number of expected fractures by approximately 5% over a 5-year period, preventing approximately 30,000 fractures for 1 million patients. Secondary fracture prevention intervention resulted in an average cost savings of $418 and an increase in QALYs of 0.0299 per patient over the lifetime; for 1 million patients who receive the intervention instead of usual care, expected cost savings for Medicare would be $418 million dollars. One-way and probabilistic sensitivity analyses supported base-case findings of cost savings. CONCLUSION: Secondary fracture prevention intervention for Medicare beneficiaries after a new osteoporotic fracture is very likely to both improve health outcomes and reduce healthcare costs compared with usual care. Expansion of its use for this population is strongly recommended.

Healthcare Policy Changes in Osteoporosis Can Improve Outcomes and Reduce Costs in the United States.

In the United States, osteoporosis affects over 10 million adults, has high societal costs ($22 billion in 2008), and is currently being underdiagnosed and undertreated. Given an aging population, this burden is expected to rise. We projected the fracture burden in US women by modeling the expected demographic shift as well as potential policy changes. With the anticipated population aging and growth, annual fractures are projected to increase from 1.9 million to 3.2 million (68%), from 2018 to 2040, with related costs rising from $57 billion to over $95 billion. Policy-driven expansion of case finding and treatment of at-risk women could lower this burden, preventing 6.1 million fractures over the next 22 years while reducing payer costs by $29 billion and societal costs by $55 billion. Increasing use of osteoporosis-related interventions can reduce fractures and result in substantial cost-savings, a rare and fortunate combination given the current landscape in healthcare policy. © 2019 The Authors. JBMR Plus published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.

Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial.

In the randomized, placebo-controlled, double-blind phase 3 ACTIVE study (NCT01343004), 18 months of abaloparatide 80 µg daily (subcutaneous injection) in postmenopausal women at risk of osteoporotic fracture significantly reduced the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and significantly increased bone mineral density (BMD) versus placebo regardless of baseline risk factors. Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months. This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups. Baseline risk subgroups included BMD T-score at the lumbar spine, total hip, and femoral neck (≤ - 2.5 versus > - 2.5 and ≤ -3.0 versus > - 3.0), history of nonvertebral fracture (yes/no), prevalent vertebral fracture (yes/no), and age (<65 versus 65 to <75 versus ≥75 years). Forest plots display treatment effect. Treatment-by-subgroup interactions were tested using the Breslow-Day test, Cox proportional hazards model, and ANCOVA model. After the combined ACTIVE-ACTIVExtend study period, reductions in relative risk for new vertebral, nonvertebral, clinical, and major osteoporotic fractures were greater among patients in the abaloparatide/alendronate group than among those in the placebo/alendronate group across all nine baseline risk subgroups. BMD gains at the lumbar spine, total hip, and femoral neck were greater in the abaloparatide/alendronate group versus the placebo/alendronate group. No clinically meaningful interaction between treatment assignment and any baseline risk variable was observed. The sequence of abaloparatide for 18 months followed by alendronate for up to 24 months appears to be an effective treatment option for a wide range of postmenopausal women at risk for osteoporotic fractures. © 2019 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc.

Lack of Evidence Linking Calcium With or Without Vitamin D Supplementation to Cardiovascular Disease in Generally Healthy Adults: A Clinical Guideline From the National Osteoporosis Foundation and the American Society for Preventive Cardiology.

DESCRIPTION: Calcium is the dominant mineral present in bone and a shortfall nutrient in the American diet. Supplements have been recommended for persons who do not consume adequate calcium from their diet as a standard strategy for the prevention of osteoporosis and related fractures. Whether calcium with or without vitamin D supplementation is beneficial or detrimental to vascular health is not known. METHODS: The National Osteoporosis Foundation and American Society for Preventive Cardiology convened an expert panel to evaluate the effects of dietary and supplemental calcium on cardiovascular disease based on the existing peer-reviewed scientific literature. The panel considered the findings of the accompanying updated evidence report provided by an independent evidence review team at Tufts University. RECOMMENDATION: The National Osteoporosis Foundation and American Society for Preventive Cardiology adopt the position that there is moderate-quality evidence (B level) that calcium with or without vitamin D intake from food or supplements has no relationship (beneficial or harmful) to the risk for cardiovascular and cerebrovascular disease, mortality, or all-cause mortality in generally healthy adults at this time. In light of the evidence available to date, calcium intake from food and supplements that does not exceed the tolerable upper level of intake (defined by the National Academy of Medicine as 2000 to 2500 mg/d) should be considered safe from a cardiovascular standpoint.

The National Osteoporosis Foundation's methods and processes for developing position statements.

The methods and processes described in this manuscript have been approved and adopted by the NOF Board of Trustees on November 11, 2015. This manuscript has been peer-reviewed by the NOF Research Committee and Osteoporosis International. The National Osteoporosis Foundation frequently publishes position statements for the benefit of educating healthcare professionals and the general public on a particular issue and/or concern related to preventing osteoporosis and/or promoting strong bones throughout the lifespan. This manuscript represents the official methods and processes adopted by the NOF Board of Trustees for the purpose developing future position statements in a transparent and unbiased manner.

Exemestane Use in Postmenopausal Women at High Risk for Invasive Breast Cancer: Evaluating Biomarkers of Efficacy and Safety.

This phase II trial evaluated clinical markers of efficacy and safety of exemestane in postmenopausal women at increased risk for breast cancer. Postmenopausal women (n = 42) at risk for invasive breast cancer received 25 mg exemestane daily for 2 years along with calcium and vitamin D. The primary outcome was change in mammographic density (MD) after one year. Secondary outcomes included change in serum steroid hormones as well as change in trefoil protein 1 (TFF1) and proliferating cell nuclear antigen (PCNA) in breast tissue. Safety and tolerability were also assessed. MD decreased at 1 year and was significant at 2 years [mean change = -4.1%; 95% confidence intervals (CI), -7.2 to -1.1; P = 0.009]. Serum estradiol and testosterone levels significantly decreased at 3 months and remained suppressed at 12 months. After 1 year of treatment, TFF1 intensity decreased (mean change -1.32; 95% CI, -1.87 to -0.76; P < 0.001). Exemestane was safe and well tolerated. Exemestane decreased MD and expression of breast tissue TFF1. It was well tolerated with few clinically relevant side effects. MD and breast tissue TFF1 are potential biomarkers of breast cancer-preventive effects of exemestane in high-risk postmenopausal women.

Burden of illness for osteoporotic fractures compared with other serious diseases among postmenopausal women in the United States.

OBJECTIVES: To provide a national estimate of the incidence of hospitalizations due to osteoporotic fractures (OFs) in women; compare this with the incidence of myocardial infarction (MI), stroke, and breast cancer; and assess temporal trends in the incidence and length of hospitalizations. PATIENTS AND METHODS: The study included all women 55 years and older at the time of admission, admitted to a hospital participating in the US Nationwide Inpatient Sample for an outcome of interest. We performed a retrospective analysis of hospitalizations for OFs (hip, forearm, spine, pelvis, distal femur, wrist, and humerus), MI, stroke, or breast cancer, using the US Nationwide Inpatient Sample, 2000-2011. RESULTS: From 2000 to 2011, there were 4.9 million hospitalizations for OF, 2.9 million for MI, 3.0 million for stroke, and 0.7 million for breast cancer. Osteoporotic fractures accounted for more than 40% of the hospitalizations in these 4 outcomes, with an age-adjusted rate of 1124 admissions per 100,000 person-years. In comparison, MI, stroke, and breast cancer had age-adjusted incidence rates of 668, 687, and 151 admissions per 100,000 person-years, respectively. The annual total population facility-related hospital cost was highest for hospitalizations due to OFs ($5.1 billion), followed by MI ($4.3 billion), stroke ($3.0 billion), and breast cancer ($0.5 billion). CONCLUSION: These data provide evidence that in US women 55 years and older, the hospitalization burden of OFs and population facility-related hospital cost is greater than that of MI, stroke, or breast cancer. Prioritization of bone health and supporting programs such as fracture liaison services is needed to reduce this substantial burden.

Before the breaking point: reducing the risk of osteoporotic fracture.

Osteoporosis is a major cause of morbidity in the United States, resulting in approximately 2 million fractures and contributing to 65,000 deaths annually. Organizations have published guidelines for the diagnosis and management of the disease. However, a degree of conflict exists among some of the recommendations. Several screening tools have been developed to identify fracture risk, and although the Fracture Risk Assessment tool developed by the World Health Organization has been widely adopted, other screening tests are also potentially useful. A range of medications are available for the prevention of osteoporosis in individuals who are at high risk for the disease and for the treatment of individuals who already have osteoporosis. Although some of these medications are highly effective, all have adverse-effect profiles and other caveats that require both familiarity with the characteristics of the medication and detailed knowledge of patient needs and preferences. Effective therapy is only possible with strong patient adherence to the regimen, which in turn requires that the patient have an understanding of the risks and benefits and can participate in the treatment-selection process.

Quantifying and comparing torsional strains after olecranon plating.

PURPOSE: Any torsion experienced at a fracture site will directly translate into shearing forces and has been regarded as detrimental to healing. The purpose of this study was to determine which plating system currently on the market controls torsional forces about comminuted olecranon fractures most effectively. METHODS: Five olecranon plates (Acumed, Synthes-SS, Synthes-Ti, ITS/US Implants and Zimmer) were implanted to stabilise a simulated comminuted fracture pattern in 50 fresh-frozen, cadaveric elbows. All specimens were evaluated by dual energy X-ray absorptiometry (DXA) scan to determine bone density. Three-dimensional displacement analysis was conducted to assess fragment motion through physiologic cyclic arcs of motion. The specimens were cycled through progressive physiologic loads (0.18-5.6 kg). Movements of the fragments were statistically compared amongst the different implants using one-way analysis of variance (ANOVA) and Tukey Honestly Significant Difference (HSD) post hoc comparisons with a critical significance level of α=0.05. RESULTS: DXA bone mineral densities (BMDs) ranged from 0.465 to 0.927, with an average of 0.714. The Acumed, Synthes-SS, Synthes-Ti and Zimmer plates allowed <1° of torsion up to 1.6 kg of load. The differences between these plates at this load were not statistically significant. The ITS/US Implants plate, however, allowed significantly more torsion above loads of 2.6 kg (p=0.045) compared with all other plates. The ITS/US Implants plate allowed over 2° of torsion at 2.6 kg (p=0.012), and nearly 3° at 3.6 kg (p=0.045). The Zimmer plate consistently allowed more torsion than the Acumed plate or either of the Synthes plates, but the differences were not statistically significant. CONCLUSION: Regardless of which olecranon plate is used, the authors recommend limiting postoperative rehabilitation loads to below 1.6 kg in an effort to minimise the detrimental effects of torsion on healing. If loads over 1.6 kg are anticipated, the authors recommend the use of the Acumed plate or either of the Synthes plates.

A biomechanical comparison of multidirectional nail and locking plate fixation in unstable olecranon fractures.

BACKGROUND: The main theoretic advantage of proximal olecranon fracture intramedullary fixation is decreased soft-tissue irritation and, potentially, less subsequent hardware removal. Despite this possible benefit, questions remain as to whether intramedullary devices are capable of controlling olecranon fractures to the same extent as locking plates. This study evaluates the ability of a novel multidirectional locking nail to stabilize comminuted fractures and directly compares its biomechanical performance with that of locking olecranon plates. MATERIALS AND METHODS: We implanted 8 stainless steel locking plates and stainless steel intramedullary nails to stabilize a simulated comminuted fracture in 16 fresh-frozen cadaveric elbows. Flexion-extension, varus-valgus, gap distance, and rotational 3-dimensional angular displacement analysis was conducted over a 60° motion arc (30° to 90°) to assess fragment motion through physiologic cyclic arcs of motion and failure loading. Displacements in all planes were compared. RESULTS: Both implants showed less than 1° of motion in all measured planes and allowed less than 1 mm of gapping through all loads tested until ultimate failure. All failures occurred by sudden, catastrophic means. The mean failure weight for the nail was 14.4 kg compared with 8.7 kg for the plate (P = .02). The nail survived 1102 cycles, whereas the plate survived 831 cycles (P = .06). CONCLUSION: In simulated comminuted olecranon fractures, the multidirectional locking intramedullary nails sustained significantly higher maximum loads than the locking plates. The two implants showed no significant differences in fragment control or number of cycles survived. Surgeons can expect the multidirectional locking nails to stabilize comminuted fractures at least as well as locking plates.

Comparison of olecranon plate fixation in osteoporotic bone: do current technologies and designs make a difference?

OBJECTIVES: The purpose of this study is to determine if recent innovations in olecranon plates have any advantages in stabilizing osteoporotic olecranon fractures. METHODS: Five olecranon plates (Acumed, Synthes-SS, Synthes-Ti, US Implants/ITS, and Zimmer) were implanted to stabilize a simulated comminuted fracture pattern in 30 osteoporotic cadaveric elbows. Specimens were randomized by bone mineral density per dual-energy x-ray absorptiometry scan. Three-dimensional displacement analysis was conducted to assess fragment motion through physiological cyclic arcs of motion and failure loading, which was statistically compared using one-way analysis of variance and Tukey honestly significant difference post hoc comparisons with a critical significance level of α = 0.05. RESULTS: Bone mineral density ranged from 0.546 g/cm to 0.878 g/cm with an average of 0.666 g/cm. All implants limited displacement of the fragments to less than 3 mm until sudden, catastrophic failure as the bone of the proximal fragment pulled away from the implant. The maximum load sustained by all osteoporotic specimens ranged from 1.6 kg to 6.6 kg with an average of 4.4 kg. There was no statistical difference between the groups in terms of cycles survived and maximum loads sustained. CONCLUSIONS: Cyclic physiological loading of osteoporotic olecranon fracture fixation resulted in sudden, catastrophic failure of the bone-implant interface rather than in gradual implant loosening. Recent plate innovations such as locking plates and different screw designs and positions appear to offer no advantages in stabilizing osteoporotic olecranon fractures. Surgeons may be reassured that the current olecranon plates will probably adequately stabilize osteoporotic fractures for early motion in the early postoperative period, but not for heavy activities such as those that involve over 4 kg of resistance.