Objective:
A 12-month extension to two 1-year, head-to-head trials comparing the efficacy and tolerability of FOSAMAX 70 mg Once Weekly and Actonel 35 mg Once-a-Week for the treatment of postmenopausal osteoporosis.
Study design:
- Randomized, double-blind, double-dummy, parallel-group, multicenter studies.
Patient characteristics:
- Women >40 years of age (>25 years of age if surgically menopausal); postmenopausal for at least 6 months; bone mineral density (BMD) T-score <–2.0 at the hip trochanter, total hip, femoral neck, or lumbar spine.
- Women who had taken estrogen, estrogen analogues, or selective estrogen receptor modulators within the past 6 months; or who had taken bisphosphonates or parathyroid hormone within the past year were excluded.
End points:
- Primary: Mean percent change from baseline in hip trochanter BMD at 24 months.
- Secondary: Mean percent change from baseline in total hip, femoral neck, and lumbar spine BMD at 24 months; mean percent change from baseline in biochemical markers of bone turnover at 24 months; overall safety and tolerability; and the percentage of patients reporting any upper gastrointestinal adverse event over 24 months. (Fractures were recorded as adverse events and were not a separate study end point.)
Important Information About FOSAMAX® (alendronate sodium) and FOSAMAX PLUS D
FOSAMAX and FOSAMAX PLUS D are contraindicated in patients with esophageal abnormalities which delay esophageal emptying (eg, stricture or achalasia) and in patients unable to stand or sit upright for at least 30 minutes. Patients at increased risk of aspiration should not receive FOSAMAX oral solution. FOSAMAX and FOSAMAX PLUS D are contraindicated in patients with hypocalcemia (see WARNINGS AND PRECAUTIONS) and in patients with hypersensitivity to any component of these products. Hypersensitivity reactions including urticaria and angioedema have been reported. FOSAMAX and FOSAMAX PLUS D, like other bisphosphonates, may cause local irritation of the upper gastrointestinal mucosa.
In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates that are approved for the prevention and treatment of osteoporosis. The time to onset of symptoms varied from one day to several months after starting the drug. Discontinue use if severe symptoms develop. Most patients had relief of symptoms after stopping treatment.
Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported in patients taking bisphosphonates.
Reference: 1. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package 20507470(1)-FOS.
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