• In postmenopausal women with osteoporosis, FOSAMAX is indicated for the treatment of osteoporosis to prevent fractures, including those of the hip and spine (vetebral compression fractures).
• In postmenopausal women who are at risk of developing osteoporosis, FOSAMAX is indicated for the prevention of osteoporosis to reduce the risk of future fracture.
• FOSAMAX is indicated for the treatment of osteoporosis in men to prevent fractures.
• FOSAMAX is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women.
• FOSAMAX is indicated for the treatment of Paget's disease of the bone in men and women.

FOSAMAX must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of FOSAMAX. If taken at the same time, it is likely that calcium supplements, antacids, and other oral medications will interfere with absorption of FOSAMAX. Therefore, patients must wait at least one-half hour after taking FOSAMAX before taking any other oral medication. Patients should not lie down for at least 30 minutes and until after their first food of the day.

Treatment of osteoporosis in postmenopausal women and in men

The recommended dosage is:
one 70 mg tablet once weekly or one 10 mg tablet once daily.

At the Hip

• In postmenopausal women, FOSAMAX is proven to prevent hip fractures. As shown in the FIT^a studies, FOSAMAX reduced the risk of hip fractures by 63% at 18 months (p=0.014 vs. placebo) in women with and without prior fractures.¹
• Consistent results were shown in study after study.  There was an overall 52% hip fracture risk reduction in a meta-analysis.^2,b The analysis looked at more than 7000 postmenopausal women up to 92 years of age. Included were patients with and without prior fractures and patients with varying degrees of osteoporosis.
  
• In a head-to-head study vs. risedronate,³ FOSAMAX Once Weekly reduced the biochemical markers of bone faster and demonstrated a 3-fold greater increase in total hip BMD (2.7% increase with FOSAMAX Once Weekly vs. 0.9% with risedronate daily at 12 months (p<0.001).^c
  
• In the ORAG meta-analysis,⁴ FOSAMAX showed larger reductions in nonvertebral fracture risk when compared with other osteoporosis treatments. FOSAMAX 10–40 mg showed a 49% risk reduction (p<0.01 vs. baseline); risedronate, calcitonin, raloxifene, and etidronate showed 27% (p<0.01 vs. baseline), 20%, 9%, and 1% risk reductions, respectively.^d

At the Spine

• In FIT with women with prior fracture, there was a 90% risk reduction in multiple vertebral fractures at 3 years (p<0.001 vs. placebo).⁵
• No other agent in the class has reported faster results in the spine.^6-10 There were significant increases in vertebral BMD as early as 3 months (p<0.001 vs. placebo).¹¹
• Reduced risk of multiple symptomatic vertebral fractures in just 6 months (p<0.044 vs. placebo).¹²
• In a head-to-head study,^3,13  FOSAMAX Once Weekly demonstrated a 70% greater increase in BMD at the lumbar spine at 12 months. Shown was a 50% greater increase in vertebral BMD vs. risdronate daily at 6 months (p<0.001)^e and a 70% greater increase in vertebral BMD vs. risedronate daily at 12 months (p<0.001).^f 
• In the ORAG meta-analysis,⁴ FOSAMAX showed larger reductions in vertebral fracture risk when compared to other osteoporosis treatments. FOSAMAX 5–40 mg showed a 48% (p<0.01) risk reduction; risedronate, calcitonin, raloxifene, and etidronate showed 36% (p=0.01), 21% (p=0.05), 40% (p=0.01), and 37% (p=0.02) risk reductions, respectively.^d

In clinical studies FOSAMAX was generally well tolerated. In studies of up to 
5 years in duration, side effects, which usually were mild, generally did not require discontinuation of therapy.  In a head-to-head study,³ FOSAMAX Once Weekly and risedronate^c daily demonstrated similar tolerability, including the incidence of upper-gastrointestinal and esophageal adverse experiences.

Convenient once-weekly dosing. In a study, 90% of patients preferred the once-weekly dosing of FOSAMAX over daily dosing.^14,g