Tuesday, 16 Jul 2019

You are here

NIH Workshop on Unmet Needs in Osteoporosis

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:

  1. 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. 
  2. 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.
  3. Drug Holidays: there are knowleged gaps on the the long-term effects of “drug holidays,” especially for bisphosphonates. 
  4. More research on barriers to treating osteoporosis.
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Safety Concerns Offset the Modest Improvements of Tanezumab in Osteoarthritis

JAMA reports that although tanezumab is modestly effective in moderate to severe osteoarthritis (knee or hip), with statistically significant improvements in pain and physical function, the tanezumab (TNZ) treated patients had more joint safety events and total joint replacements than patients treated with placebo.

Benefits vs Harms for Osteoporosis Drug Continuation or Discontinuation

While it is clear that long-term bisphosphonate therapies reduce fracture risk in women with osteoporosis, it is unclear how to counter-balance these benefits against rare serious harms and how to optimize therapeutic benefits with appropriate drug holidays. A systematic analysis of 48 studies compared long-term osteoporosis drug treatment (ODT) (>3 years) versus control versus ODT continuation versus durg discontinuation, to examine incident fractures or harms.

Mortality from Falls in the Elderly

JAMA reports that there is a trend of increasing mortality from falls in older US adults between 2000 to 2016 and that mortality rates are increased with increasing age. 

Knee Injuries Increases Osteoarthritis Risk

A systematic review of the medical literature shows anterior cruciate ligament (ACL), meniscus or combined ACL and meniscus injury significantly increases the risk of future knee osteoarthritis (OA).

The metanalysis comprised 53 studies and nearly 1 million participants, including 185,219 with ACL injury (mean age 28 years), 83,267 with meniscal injury (mean 38 years) and 725,362 with combined injury (mean 31 years).

Additive Effects of Insomnia and Depression on Osteoarthritis

A study of osteoarthritis patients, finds that pain is the primary driver for health care utilization, and that the presence of insomnia or depression augments health care use.

 A total of 2976 OA patients were followed for 3 years and assessed for pain (Graded Chronic Pain Scale), insomnia (Insomnia Severity Index), and depression (Patient Health Questionnaire‐8), and health care use (from electronic health records).