NIH Workshop on Unmet Needs in Osteoporosis Save
In October 2018, the National Institutes of Health (NIH) convened a workshop to address the "Appropriate Use of Drug Therapies for Osteoporotic Fracture Prevention"
They specifically examined the evidence on long-term (>3 years) use to prevent osteoporotic fractures and identify research gaps and needs for advancing the field. The Annals of Internal Medicine has published the final report summarizing the panel's recommendations.
The report reviews that and estimated that 8 million adult women and 2 million men have osteoporosis (8), and 27 million women and 16 million men have low bone mass. Moreover by 2025, it is estimated that the U.S. health care costs attributable to OP fractures will reach $25 billion annually.
While there are many FDA approved pharmacologic treatments that may prevent fractures, it is estimated that many at high fracture risk remain untreated. One study has shown that less than 20% of women received osteoporosis treatment in the year after diagnosis of an initial fragility fracture.
Highlights from the workshop include:
- Need for new trials and new trial designs - in addition to fracture outcomes, more data is needed on patient morbidity and survival, sequelae of fractures, functional status, mobility, hospitalizations, etc.
- More data on rare events such as atypical femoral fractures (AFFs) and osteonecrosis of the jaw (ONJ). Data from observational studies and postmarketing surveillance suggests that the age-adjusted incidence rates for AFFs is 1.78 per 100 000 person-years (95% CI, 1.5 to 2.0 per 100 000 person-years) with bisphosphonate exposure of 0.1 to 1.9 years, and increased to 113.1 per 100 000 person-years (CI, 69.3 to 156.8 per 100 000 persons per year) with bisphosphonate exposure of 8 to 9.9 years (16). For ONJ, the incidence is 1 to 69 per 100 000 patient-years with oral bisphosphonates and 0 to 90 per 100 000 patient-years with intravenous bisphosphonates. These incidence rates are marginally higher than those of the general patient population.
- Drug Holidays: there are knowleged gaps on the the long-term effects of “drug holidays,” especially for bisphosphonates.
- More research on barriers to treating osteoporosis.