NOF Statement in Response to the New York Times’ article: “Spinal Fractures Can Be Terribly Painful. A Common Treatment Isn’t Helping” by Gina Kolata, January 24, 2019.
We appreciate the New York Times’ coverage of spinal fractures and two procedures used to treat them (vertebroplasty and kyphoplasty), but we have serious concerns with its implication about NOF’s position on those procedural treatments for fractures. We recognize the ASBMR’s Task Force efforts to review the efficacy and safety of two FDA-approved osteoporotic spinal fracture treatments. NOF agrees with the Task Force’s message that “procedures to stabilize spinal fractures should not be a first choice for treatment.” However, as the report also points out, content which was not covered in the article, there are areas for which objective evidence is weak or non-existent. We hope that ASBMR, as the leading bone research society, will work to determine evidence gaps and share all research related to FDA approved treatments (pharmacological and procedural). As the nation’s preeminent patient advocacy organization, it is NOF’s mission to provide clinicians and patients with the full scope of options (and the related research) available to make an informed decision on risk versus benefit for every osteoporosis treatment.
Annually, there are an estimated 2 million osteoporotic fractures, resulting in over 500,000 hospitalizations and over 2.5 million physician visits. In the population over 50 years of age, 50% of women and 20-30% of men will suffer an osteoporotic fracture in their lifetime. The financial cost of fracture care was $16.9 billion in 2005, expected to rise to $25.3 billion by 2025. Beyond the financial cost, osteoporotic fractures cause pain and suffering, decreased quality of life (as reflected in the approximately 180,000 nursing home admissions annually), loss of independence and mobility, and high mortality rates, with about 20-30% of patients dying in the year following a hip fracture. Mortality may be increased after painful vertebral fractures as well.
As we consider the complex and often imperfect options for treating this debilitating and chronic disease, we must review the totality of the data and acknowledge that clinicians face important decisions with individual patients, many of whom will not be candidates for procedural treatment, but for some it will be appropriate and successful. The ASBMR task force included only specific types of research, but in this setting, when the kind of trials that are needed are hard to do or even unethical to do, it is critical to examine all data that is available.
NOF does not have a formal position statement on VCF, but we did share the following with the New York Times; unfortunately none of it was included in the article:
- As the leading patient advocacy organization in the bone health field, we agree with ASBMR that patients need to be fully informed of the evidence and, with guidance from experienced expert clinicians, make the best evidence-based decisions about their care.
- The Task Force Report serves to highlight the importance of and difficulties faced in treating patients with vertebral fractures and resulting pain/disability/reduced QOL.
- Several of the recommendations (mainly those pertaining to non-vertebroplasty procedures including kyphoplasty) are based on low quality evidence and deemed weak and reflect overall deficiencies in clinical research and available data. In essence, the review was limited by the lack of available good quality data.
- Ideally, we need more research in the field in this area—but some of the research may not be feasible/able to be conducted due to patient safety concerns, trial designs that would be required.
- This is an FDA approved procedure.
- There is a place for this procedure in a surgeon’s armamentarium of options for patients. Options are important.
- The report acknowledges that optimal management of VFs is uncertain. We may need better characterization of the types of patients who will absolutely benefit from this procedure (cancer patients, patients who have recently fractured, others).
- It is critical that patients with vertebral fractures are treated with osteoporosis medications to treat the underlying condition and reduce the risk for future fractures.
We believe that patients and clinicians deserve all the known information – even when it is complicated or nuanced, even when it means that we don’t have definitive answers but need more research. We welcome your thoughts or concerns about The New York Times article, the ASBMR Task Force report, and/or NOF’s efforts to provide educational information about all osteoporosis treatments. Please contact Elizabeth Thompson, Chief Executive Officer, at email@example.com or Claire Gill, Chief Mission Officer, at firstname.lastname@example.org.