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New NOF Guidelines and the WHO Fracture Assessment Tool or FRAX

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New NOF Guidelines and the WHO Fracture Assessment Tool or FRAX

March 18, 2008

The National Osteoporosis Foundation has released a 2008 update to the NOF guidelines last published in 1999. The guidelines, which are evidence based whenever possible, provide recommendations for screening, counseling and treatment of osteoporosis. This update was prompted by the publication of the FRAX, a new fracture risk assessment tool.

FRAX

The World Health Organization has developed this new fracture risk assessment tool  to identify individuals at high risk of osteoporotic fracture  The current standard, which bases treatment decisions largely on bone mineral density measurement, has proven to be specific, but not sensitive, for the identification of patients at high risk of fracture.  Because nearly 50% of postmenopausal women in the community over the age of 50 years who suffer an osteoporotic fracture do not have osteoporosis defined by a BMD test1,2, and because of the limited availability of BMD in many countries, clinical risk factors were added to BMD to identify patients at high risk for osteoporotic fractures3. 

A task force from the WHO evaluated the clinical risk factors that predict increased risk of fracture in nearly all of the 12 population cohorts evaluated worldwide.  These are:

  • Age
  • Sex
  • Prior fragility fracture after age 50
  • History of corticosteroid use (5 mg or more for three months or more)
  • Parental history of hip fracture
  • Rheumatoid arthritis
  • Secondary osteoporosis (e.g., type 1 diabetes, osteogenesis imperfecta in adults, longstanding hyperthyroidism, hypogonadism, premature menopause, chronic malabsorption and chronic liver disease)
  • Current smoker
  • Alcohol use of greater than 2 units daily (a unit is one medium glass of wine or a glass of beer)
  • Body Mass Index

FRAX integrates the future osteoporotic fracture risk associated with clinical risk factors with that associated with femoral neck BMD.  BMD of the femoral neck (although less data is available, the total hip may also be used in women) tracks in parallel to BMI except at very low BMI, so that BMI may be used when BMD is unavailable.  BMI and BMD would not be used in the same individual.  The incident rates of fractures are country specific and provide the clinician the 10 year probability of hip fracture and the 10 year probability of major osteoporotic fracture (clinical vertebral, forearm, hip and shoulder).  FRAX is currently being validated in additional longitudinal cohort databases. It is anticipated that in the latter half of 2008, the FRAX will be available as a software update for DXA equipment.  FRAX is now available to clinicians online at www.shef.ac.uk/FRAX/ 4,5.
           
The FRAX provides an estimated fracture risk in a given individual but does not identify the level of fracture risk at which treatment should be started (“intervention threshold”).  The intervention threshold decision is based on the willingness of a given country or region to pay for the treatments recommended. For example, in the United Kingdom and Sweden osteoporosis treatment is calculated to be cost-effective for a  4% ten year risk of hip fracture, while in the United States osteoporosis treatment is calculated to be cost-effective with ten  year risk of a hip fracture of 3%.

Limitations

The FRAX model is a model in progress. It does not include spinal BMD data or bone turnover markers, as bone marker data is not available from many of the countries that contributed longitudinal cohorts to generate the FRAX.  Also, FRAX does not include data on BMD measured at the peripheral skeletal sites.  Most patients studied for fracture risk were women, and data on ethnic groups in the US are limited.  The FRAX cannot be used in patients who have been treated with osteoporosis medications since the probability of fracture may be overestimated. Patients being assessed for osteoporotic fracture risk may not be able to make a treatment decision based on a 10 year probability of a fracture, although the one-year probability would be 10% of a ten-year probability.

The New NOF Guidelines

Role of physicians who evaluate, prevent and treat osteoporosis in postmenopausal women and men age 50 and older:

  • Counsel on the risk of osteoporosis and related fractures
  • Check for secondary causes
  • Advise on adequate calcium and vitamin D intake
  • Recommend regular weight bearing and muscle strengthening exercise to reduce risk of falls and fractures
  • Advise avoidance of tobacco smoking and excessive alcohol intake

BMD testing is advised for:

  • Women age 65 and older
  • Men age 70 and older
  • In younger postmenopausal women and men age 50 and older based on risk factor profile
  • Those with a fracture to determine degree of disease severity

Treatment is recommended for:

  • Patients with hip or vertebral fracture (clinical or morphometric)
  • Patients with osteoporosis as defined by T score <=-2.5
  • Postmenopausal women or men age 50 and older with low bone mass (T score -1 to -2.5, osteopenia) at the femoral neck, total hip, or spine and 10 year hip fracture risk probability >3% or a 10 year all major osteoporosis related fracture probability of >20% based on the U.S. adapted WHO absolute fracture risk model

BMD should be monitored two years after initiating therapy and at two-year intervals thereafter.

Bottom Line:

  • BMD measurement alone fails to identify a high number of subjects who subsequently develop fractures. The addition of clinical risk factors may indeed be an improvement in risk factor assessment.
  • While FRAX provides a method to evaluate fracture risk with and without BMD to use for global health, understanding exactly what level of fracture risk is appropriate for therapeutic intervention probably requires additional research. 

Hotline Authors: Nancy E. Lane¸ MD, University of California at Davis; Stuart Silverman, MD, Private Practice and Clinical Professor of Medicine, University of California at Los Angeles.

Hotline Editors: Arthur Kavanaugh, MD; Eric Matteson, MD, MPH; Eric Ruderman, MD.

Disclosures:  Drs. Lane and Silverman have nothing to disclose. Drs. Kavanaugh, Matteson and Ruderman have nothing to disclose.

The ACR Hotline is provided by the ACR Communications and Marketing Committee as a service to members. This Hotline reflects the views of the author(s) and does not represent a position statement of the American College of Rheumatology.

  1. Siris ES, Brenneman SK, Miller PD, et al.  Predictive value of low BMD for 1-year fracture outcomes is similar for postmenopausal women ages 50-64 and 65 and Older: results from the National Osteoporosis Risk Assessment (NORA).  J Bone Miner Res. 2004 Aug;19(8):1215-20.
  2. Siris ES, Miller PD, Barrett-Connor E, et al  Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment.  JAMA. 2001 Dec 12;286(22):2815-22.
  3. Cummings SR, Nevitt MC, Browner WS, et al .  Risk factors for hip fracture in white women. Study of Osteoporotic Fractures Research Group. N Engl J Med. 1995 Mar 23;332(12):767-73.
  4. Kanis JA, Oden A, Johnell O, et al .  The use of clinical risk factors enhances the performance of BMD in the prediction of hip and osteoporotic fractures in men and women. Osteoporos Int. 2007 Aug;18(8):1033-46.

     

  5. Dawson-Hughes B, Tosteson AN, Melton LJ 3rd, , et al.  Implications of absolute fracture risk assessment for osteoporosis practice guidelines in the USA  Osteoporos Int. 2008 Feb 22.

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