Updated Osteoporosis Guideline Addresses a Broader Population

By John Gever
WASHINGTON, Feb. 22 -- Non-Caucasian women and men over 50 are covered for the first time in new guidelines for prevention and treatment of osteoporosis issued here by the National Osteoporosis Foundation.
The new guide also substantially bumps up the recommended daily intake of vitamin D3 -- to 800 to 1,000 IU from 400 to 600 -- for most people over 50.
The new version includes the following specific recommendations for identifying postmenopausal women and men age 50 and over who should be treated:
A hip or vertebral (clinical or morphometric) fracture
Other prior fractures and low bone mass (bone mineral density T-score from -1.0 to -2.5 at the femoral neck, total hip, or spine)
T-score < -2.5 at the femoral neck, total hip or spine after appropriate evaluation to exclude secondary causes
Low bone mass (T-score from -1.0 to -2.5 at the femoral neck, total hip, or spine) and secondary causes associated with high risk of fracture (such as glucocorticoid use or total immobilization)
Low bone mass (T-score from -1.0 to -2.5 at the femoral neck, total hip, or spine) and 10-year probability of hip fracture ≥3% or a 10-year probability of any major osteoporosis-related fracture ≥ 20% based on the World Health Organization's FRAX model for evaluating 10-year fracture risk, adapted for U.S. women.
WHO's model is based on bone mineral density and nine specific clinical risk factors for osteoporosis and related fractures.
They include age, gender, fracture history, parental hip fracture history, oral steroid therapy, low body mass index, femoral neck bone mineral density, secondary osteoporosis, current smoking, and alcohol intake of at least three drinks daily.
In a press release, the foundation said that dual-energy x-ray absorptionometry instruments now in development will incorporate software to analyze these factors in conjunction with bone mineral density readings. These devices are expected to produce instant reports on patients' 10-year fracture risk.
Currently, clinicians can use an online calculator at the following website: www.shef.ac.uk/FRAX/
Clinicians should note that the WHO model applies only to patients previously untreated for osteoporosis, according to the foundation.
The foundation's guideline development committee, chaired by Bess Dawson-Hughes, M.D., of Tufts University in Boston, adapted this algorithm for the United States to incorporate fracture outcome and mortality data for U.S. women and men as well as a cost-effectiveness analysis to determine when it makes sense to prescribe osteoporosis medications.
Two position papers published online in Osteoporosis International provide details on the adaptation. In them, Dr. Dawson-Hughes and colleagues explained that osteoporosis treatment became cost-effective when the 10-year probability of hip fracture according to the WHO model was at least 3%.
For patients in their 70s and 80s, 10-year fracture risk probability had to surpass about 4% to be cost-effective.
The threshold did not vary substantially between genders or among racial and ethnic groups, although it tended to be slightly higher for men than for women, the researchers said.
The calculation was based on an estimated drug cost of $600 per year for five years with a 35% reduction in fracture rate. The maximum cutoff for cost-effectiveness was set at $60,000 per quality-adjusted life-year gained.
Putting the algorithm at the heart of the new guide "dramatically alters the approach to assessing fracture and risk treatment," Dr. Dawson-Hughes said.
"It provides evidence-based recommendations to help healthcare providers better identify people at high risk for developing osteoporosis and fractures and assures that those at highest risk are recommended for treatment to lower that risk."
The new guide also adds zoledronate (Reclast) to the list of available bisphosphonate drugs. Additionally, it adds two medications now available in Europe, strontium ranelate and parathyroid hormone 1-84PTH to its list of drugs that physicians may consider prescribing off-label.
It also covers prevention steps, including recommended calcium and vitamin D intake, exercise, tobacco cessation, and alcohol reduction.
The new guide and supporting documents, including the Osteoporosis International papers, can be downloaded at the foundation's website: www.nof.org/professionals/Clinicians_Guide.htm
The guidelines were prepared in collaborated with physician representatives of 18 medical societies, including the American Association of Clinical Endocrinologists, the American College of Radiology, the American Orthopaedic Association, and the International Society for Physical Medicine and Rehabilitation.
Development of the guidelines was funded by the National Osteoporosis Foundation.
The research published in Osteoporosis International was funded by the National Osteoporosis Foundation and the National Institutes of Health.
Members of the guideline development committee reported no potential conflicts of interest.
Primary source: National Osteoporosis FoundationSource reference:National Osteoporosis Foundation "Clinician's guide to prevention and treatment of osteoporosis" 2008. Additional source: Osteoporosis InternationalSource reference: Tosteson A, et al., "Cost-effective osteoporosis treatment thresholds: the U.S. perspective from the National Osteoporosis Foundation Guide Committee" Osteoporosis International 2008; DOI:1007/s00198-007-0544-4. Additional source: Osteoporosis InternationalSource reference: Dawson-Hughes B, et al., "Implications of absolute fracture risk assessment for osteoporosis practice guidelines in the U.S." Osteoporosis International 2008; DOI: 10.1007/s000198-007-0559-5.