Results from First Comparative Study Show Fosamax-R- Increased BMD in the Hip and Spine More Than Actonel in Postmenopausal Women with Osteoporosis

Business Wire, Sept 29, 2002

Concomitant use with estrogen/hormone replacement therapy

In two studies (of one and two years' duration) of postmenopausal osteoporotic women (total: n equal to 853), the safety and tolerability profile of combined treatment with FOSAMAX 10 mg once daily and estrogen /- progestin (n equal to 354) was consistent with those of the individual treatments.

Treatment of glucocorticoid-induced osteoporosis

In two, one-year, placebo-controlled, double-blind, multicenter studies in patients receiving glucocorticoid treatment, the overall safety and tolerability profiles of FOSAMAX 5 and 10 mg/day were generally similar to that of placebo. The adverse experiences considered by the investigators as possibly, probably, or definitely drug related in equal to or greater than 1% of patients treated with either FOSAMAX 5 or 10 mg/day or placebo are presented in the following table.

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               One-Year Studies in Glucocorticoid-Treated Patients
              Adverse Experiences Considered Possibly, Probably, or
                 Definitely Drug Related by the Investigators and
      Reported in equal to or greater than 1% of Patients

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                             FOSAMAX           FOSAMAX     Placebo
                            10 mg/day          5 mg/day
                                %                 %           %
                             (n equal         (n equal    (n equal
                              to 157)          to 161)     to 159)
                             -------           -------     -------
 Gastrointestinal
     abdominal pain            3.2               1.9         0.0
     acid regurgitation        2.5               1.9         1.3
     constipation              1.3               0.6         0.0
     melena                    1.3               0.0         0.0
     nausea                    0.6               1.2         0.6
     diarrhea                  0.0               0.0         1.3
 Nervous System/Psychiatric
     headache                  0.6               0.0         1.3
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The overall safety and tolerability profile in the glucocorticoid-induced osteoporosis population that continued therapy for the second year of the studies (FOSAMAX: n equal to 147) was consistent with that observed in the first year.

Paget's disease of bone

In clinical studies (osteoporosis and Paget's disease), adverse experiences reported in 175 patients taking FOSAMAX 40 mg/day for 3-12 months were similar to those in postmenopausal women treated with FOSAMAX 10 mg/day. However, there was an apparent increased incidence of upper gastrointestinal adverse experiences in patients taking FOSAMAX 40 mg/day (17.7% FOSAMAX vs. 10.2% placebo). One case of esophagitis and two cases of gastritis resulted in discontinuation of treatment.

Additionally, musculoskeletal (bone, muscle or joint) pain, which has been described in patients with Paget's disease treated with other bisphosphonates, was considered by the investigators as possibly, probably, or definitely drug related in approximately 6% of patients treated with FOSAMAX 40 mg/day versus approximately 1% of patients treated with placebo, but rarely resulted in discontinuation of therapy. Discontinuation of therapy due to any clinical adverse experience occurred in 6.4% of patients with Paget's disease treated with FOSAMAX 40 mg/day and 2.4% of patients treated with placebo.