Osteoporosis-related Vertebral Fragility Fractures: A Review and Analysis of the American Orthopaedic Association's Own the Bone Database.

STUDY DESIGN: Retrospective cohort study of the Own the Bone database which is a fracture liaison service designed to improve recognition and treatment of osteoporosis. OBJECTIVE: To use the Own the Bone (OTB) database to 1) examine the specific demographics of patients presenting with a low-energy clinical vertebral fracture (VFX) and 2) compare demographic and fracture-specific risk factors between patients with clinical VFX versus patients with nonvertebral low-energy fracture (NVFX). SUMMARY OF BACKGROUND DATA: Large database studies have described risk factors for developing VFX. It is well described that a history of previous VFX portends an increased risk of future VFX. Few studies have reported cohorts from a fracture liaison service such as the OTB initiative. METHODS: 35,039 unique cases of fragility fracture occurred between 2009 and 2016 and were included in analysis. VFX accounted for 3395 (9.9%) of the presenting fractures at OTB enrollment. The demographics, lifestyle factors, medication use, and fracture-specific data for patients in the OTB registry with vertebral fractures were summarized and then statistically compared to those with nonvertebral fragility fractures. RESULTS: The majority of VFX patients were Caucasian, postmenopausal women (74.4%). There was an increased likelihood of presenting with a vertebral fracture in patients who sustained a previous VFX after the age of 50, while patients who sustained a prior nonvertebral fracture (NVFX) were more likely to present with a subsequent NVFX. After controlling for patients with a history of fracture after the age of 50, VFX patients (vs. NVFX) were more likely to be age 70-79, class 1 obesity, with a history of taking anti-osteoporotic prescription medications. CONCLUSIONS: Multiple factors were associated with a significantly increased risk of VFX compared with NVFX. Understanding the risk factors unique to fragility VFX is a critical component for targeting "at-risk" patients and preventing future osteoporosis-related fractures and their consequences. LEVEL OF EVIDENCE: 4.

Own the Bone, a System-Based Intervention, Improves Osteoporosis Care After Fragility Fractures.

BACKGROUND: The goal of this study was to evaluate the effectiveness of the American Orthopaedic Association's Own the Bone secondary fracture prevention program in the United States. METHODS: The objective of this quality improvement cohort study was dissemination of Own the Bone and implementation of secondary prevention (osteoporosis pharmacologic and bone mineral density [BMD] test recommendations). The main outcome measures were the number of sites implementing Own the Bone and implementation of secondary prevention, i.e., orders for BMD testing and/or pharmacologic treatment. The 177 sites participating in the program were academic and community hospitals, orthopaedic surgery groups, and a health system; data were obtained from the first 125 sites utilizing its registry, between January 1, 2010, and March 31, 2015. It included all patients, aged 50 years or older, presenting with fragility fractures (n = 23,132) who were enrolled in the Own the Bone web-based registry. The interventions were education, development of program elements, dissemination, implementation, and evaluation of the Own the Bone program at participating sites. RESULTS: A growing number of institutions implemented Own the Bone (14 sites in 2005-2006 to 177 sites in 2015). After consultation, 53% of patients had a BMD test ordered and/or pharmacologic therapy for osteoporosis. CONCLUSIONS: The Own the Bone intervention has succeeded in improving the behaviors of medical professionals in the areas of osteoporosis treatment and counseling, BMD testing, initiation of pharmacotherapy, and coordination of care for patients who have experienced a fragility fracture.

Acute kidney injury and bisphosphonate use in cancer: a report from the research on adverse drug events and reports (RADAR) project.

PURPOSE: To determine whether acute kidney injury (AKI) is identified within the US Food and Drug Administration's Adverse Events and Reporting System (FDA AERS) as an adverse event resulting from bisphosphonate (BP) use in cancer therapy. METHODS: A search of the FDA AERS records from January 1998 through June 2009 was performed; search terms were "renal problems" and all drug names for BPs. The search resulted in 2,091 reports. We analyzed for signals of disproportional association by calculating the proportional reporting ratio for zoledronic acid (ZOL) and pamidronate. Literature review of BP-associated renal injury within the cancer setting was conducted. RESULTS: Four hundred eighty cases of BP-associated acute kidney injury (AKI) were identified in patients with cancer. Two hundred ninety-eight patients (56%) were female; mean age was 66 ± 10 years. Multiple myeloma (n = 220, 46%), breast cancer (n = 98, 20%), and prostate cancer (n = 24, 5%) were identified. Agents included ZOL (n = 411, 87.5%), pamidronate (n = 8, 17%), and alendronate (n = 36, 2%). Outcomes included hospitalization (n = 304, 63.3%) and death (n = 68, 14%). The proportional reporting ratio for ZOL was 1.22 (95% CI, 1.13 to 1.32) and for pamidronate was 1.55 (95% CI, 1.25 to 1.65), reflecting a nonsignificant safety signal for both drugs. CONCLUSION: AKI was identified in BP cancer clinical trials, although a safety signal for BPs and AKI within the FDA AERS was not detected. Our findings may be attributed, in part, to clinicians who believe that AKI occurs infrequently; ascribe the AKI to underlying premorbid disease, therapy, or cancer progression; or consider that AKI is a known adverse drug reaction of BPs and thus under-report AKI to the AERS.

Bisphosphonates and nonhealing femoral fractures: analysis of the FDA Adverse Event Reporting System (FAERS) and international safety efforts: a systematic review from the Research on Adverse Drug Events And Reports (RADAR) project.

BACKGROUND: In the United States, hip fracture rates have declined by 30% coincident with bisphosphonate use. However, bisphosphonates are associated with sporadic cases of atypical femoral fracture. Atypical femoral fractures are usually atraumatic, may be bilateral, are occasionally preceded by prodromal thigh pain, and may have delayed fracture-healing. This study assessed the occurrence of bisphosphonate-associated nonhealing femoral fractures through a review of data from the U.S. FDA (Food and Drug Administration) Adverse Event Reporting System (FAERS) (1996 to 2011), published case reports, and international safety efforts. METHODS: We analyzed the FAERS database with use of the proportional reporting ratio (PRR) and empiric Bayesian geometric mean (EBGM) techniques to assess whether a safety signal existed. Additionally, we conducted a systematic literature review (1990 to February 2012). RESULTS: The analysis of the FAERS database indicated a PRR of 4.51 (95% confidence interval [CI], 3.44 to 5.92) for bisphosphonate use and nonhealing femoral fractures. Most cases (n = 317) were attributed to use of alendronate (PRR = 3.32; 95% CI, 2.71 to 4.17). In 2008, international safety agencies issued warnings and required label changes. In 2010, the FDA issued a safety notification, and the American Society for Bone and Mineral Research (ASBMR) issued recommendations about bisphosphonate-associated atypical femoral fractures. CONCLUSIONS: Nonhealing femoral fractures are unusual adverse drug reactions associated with bisphosphonate use, as up to 26% of published cases of atypical femoral fractures exhibited delayed healing or nonhealing.

Addressing secondary prevention of osteoporosis in fracture care: follow-up to "own the bone".

The majority of the 1.8 million individuals who sustain a fracture annually in the United States have osteopenia or osteoporosis, yet <15% of these patients subsequently receive treatment for osteoporosis. A prospective cohort study was conducted to assess the effect of two different interventions on the rate of osteoporosis treatment in patients with a fragility fracture. Patients who were fifty years of age or older and were hospitalized for the treatment of a fragility fracture at either of two academic institutions were eligible for inclusion in the study. The intervention at one hospital involved immediate care for osteoporosis, including initiation of pharmacologic therapy during hospitalization. The intervention at the other hospital involved delayed care, including recommendations for osteoporosis counseling, bone-mineral density testing, and potential treatment for osteoporosis that were communicated to the primary care physician after the patient was discharged from the hospital. Patients were surveyed by telephone six months after the fracture, and their medical and pharmacy records were reviewed to verify the osteoporosis treatment that they had received. The mean age was 73 ± 10 years in the immediate-care group and 74 ± 12 years in the delayed-care group. Eighty percent of the patients were women. Sixty-five percent of the patients in each group completed the telephone interview six months after the fracture, and most had seen their primary care physician and undergone bone-mineral density testing. The rate of bone-mineral density testing was 92% in the immediate-care group compared with 76% in the delayed-care group. Both immediate and delayed care for osteoporosis resulted in a significant increase in the treatment rate compared with the baseline rate of 0% (p < 0.001). However, the primary care physician had initiated osteoporosis therapy by six months after the fracture in only 30% of the patients in the delayed-care group compared with a treatment rate of 67% in the immediate-care group (p < 0.001). Limitations of the study include the possibility that the findings resulted from a difference between the two study centers rather than between the two strategies. In addition, because of the academic and integrated nature of the medical systems at which the study was conducted, the findings cannot necessarily be extrapolated to other types of institutions. In summary, a recommendation for osteoporosis treatment made by an orthopaedic surgeon to the patient's primary care physician resulted in an increase in the rate of bone-mineral density testing and in the rate of therapy compared with baseline. However, immediate initiation of osteoporosis care during hospitalization for the fragility fracture resulted in a higher rate of treatment--with two-thirds of the patients receiving therapy six months after the fracture--compared with delayed initiation.

It is time for everyone to own the bone.

The current status of the population's bone health has caused considerable concern in the USA and around the world. In keeping with that situation, the US Surgeon General issued a special report on Bone Health and Osteoporosis in 2004 calling attention to a rapidly increasing healthcare problem especially linked to a growing and aging population base. The report specifically cited the medical profession's failure to treat the underlying osteoporosis in elderly individuals with fragility fractures with a 20% treatment rate as the norm. It was noted that an individual fracture was a sentinel event that provided a "teachable moment" for the patient in order to prevent future fractures. Additional statistics revealed the annual total number of fragility fractures, more than two million, exceeded the combined annual total incidence of stroke, myocardial infarction, and breast cancer. Realizing that the American Heart Association and the cardiology community had a successful US national program encouraging the use of beta blockers in patients after myocardial infarction in order to prevent recurrences, the American Orthopaedic Association (AOA) embarked on a course leading to the development of a program to improve bone healthcare in elderly patients with fragility fractures. The cardiology project, "Get With The Guidelines" (GWTG), included a registry in order to document improvement in cardiac patient care. Therefore, the AOA, a leadership group of orthopaedic surgeons, decided it was time to engage the orthopaedic community in a quality improvement initiative patterned after GWTG. Thus, Own the Bone was created as a multidisciplinary program in order to engage patients and physicians from different specialties who might be involved with the bone health concerns of patients with fragility fractures. After the success of a pilot study from 2005 to 2006, Own the Bone was launched as a US national quality improvement program in 2009. It involves a turnkey protocol, utilizing a web-based registry, in order to complete ten basic measures of patient care in patients 50 years and older with fragility fractures. Those measures center on information and counseling on nutrition, physical activity, lifestyle changes, diagnosis and treatment of osteoporosis, and communication to the patient and primary care physician, mentioning the need for osteoporosis care. While this project was initially meant to be implemented in a hospital setting, it can also be applied in an outpatient clinic or emergency care facility. The program continues to expand to numerous hospitals in many states with the support of a growing number of orthopedists and allied medical specialists interested in bone health and osteoporosis. Thus, Own the Bone is a systems-based, quality improvement initiative which provides many benefits for patients with fragility fractures and their treating physicians.

Cancer therapy associated bone loss: implications for hip fractures in mid-life women with breast cancer.

PURPOSE: Aromatase inhibitors (AIs) have been recently associated with hip fractures. We present a case series of breast cancer survivors and a systematic review of bone health care in breast cancer. EXPERIMENTAL DESIGN: We completed clinical assessments and bone density testing (BMD) of hip fractures from January 2005 to December 2008. Prefracture and 12-month functional status was obtained. Systematic review included case reports and review of MEDLINE, PubMed, EMBASE, and Food and Drug Administration Adverse Event Reporting System (FDA AERS) from January 1998 to December 2008 (search terms: breast cancer, bone loss, osteopenia, osteoporosis, malignancy, cancer treatment, menopause, adriamycin, cytoxan, tamoxifen, and AIs). RESULTS: Median age was 53.5 years; five women had osteopenia, one osteoporosis. Five cases were ER (+), and received surgery, XRT chemotherapy, and anastrozole. Functional decline was noted at 12 months, with difficulty in performing heavy housekeeping, climbing stairs, and shopping. The FDA AERS database included 228 cases of fractures associated with breast cancer therapy; 77/228 (29.4%) were hip or femur fractures. Among mid-life women under the age of 64 years there were 78 fractures; 15/228 (19%) were hip and femur fractures. AIs were the most common drug class associated with fractures (n = 149, 65%). CONCLUSIONS: Cancer treatment induced bone loss results in hip fractures among mid-life women with breast cancer. Hip fractures occur at younger ages and higher BMD than expected for patients in this age group without breast cancer. Hip fractures result in considerable functional decline. Greater awareness of this adverse drug effect is needed.

Prior fractures are common in patients with subsequent hip fractures.

Treating osteoporosis in patients with prior fractures potentially results in a 50% reduction of risk of future fractures. We retrospectively reviewed 632 patients with incident hip fractures to evaluate (1) the prevalence of prior fractures in incident hip fractures, (2) whether prior fractures led to an increase in the treatment of osteoporosis, and (3) the cost utility of osteoporosis treatment after a prior fracture. The patients were treated at three hospitals from January 2000 to June 2001 and 514 (80%) were women. A minimal trauma fracture was defined as a fracture resulting from a fall while standing or walking or falling from a height less than 4 feet. Two hundred eighty-two patients (45%) with incident hip fractures described a prior minimal trauma fracture. Osteoporosis was diagnosed in 43 (13%) women and three (5%) men. In 107 cases (17%), the incident hip fracture was the second hip fracture. A prior minimal trauma fracture did not increase treatment for osteoporosis. Presuming a 50% reduction in fracture risk with medications, treating the 282 patients with prior minimal trauma fracture would have resulted in a savings of $3.5 million.

An osteoporosis and fracture intervention program increases the diagnosis and treatment for osteoporosis for patients with minimal trauma fractures.

BACKGROUND: As fewer than 25% of patients with an osteoporotic minimal trauma fracture (MTF) are evaluated and treated for osteoporosis, an osteoporosis and fracture intervention program (OFIP) was developed. METHODS: Patients hospitalized with MTF were educated about and treated for osteoporosis and were evaluated by the osteoporosis team at 6 and 12 months after discharge. Patients seen in the emergency department were given information about osteoporosis and encouraged to seek medical care at the osteoporosis office. RESULTS: While 165 patients hospitalized with an MTF participated in the OFIP, 38 patients received routine osteoporosis education. At the 6-month follow-up, in the OFIP group, 68% of patients with hip fracture and 54% of patients with non-hip fracture were taking antiresorptive medications. There was no change in treatment rate among patients receiving conventional care. CONCLUSIONS: The rates of diagnosis of osteoporosis and treatment implementation following an MTF increased when the intervention occurred at the time of hospitalization.