Sixteen percent of the alendronate sodium patients who sustained a radiologically-confirmed fracture by Month 12 of the study had delayed fracture healing (callus remodeling) or fracture non-union when assessed radiographically at Month 24 compared with 9% of the placebo-treated patients. Copy the URL below and paste it into your RSS Reader application.DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.
No significant effect was seen for total body BMD.Histomorphometric studies of transiliac biopsies in 92 subjects showed normal bone architecture. Study 1 and Study 2 were identically designed, three-year, placebo-controlled, double-blind, multicenter studies (United States and Multinational n=994); Study 3 was the three-year vertebral fracture cohort of the Fracture Intervention Trial [FIT] (n=2027) and Study 4 was the four-year clinical fracture cohort of FIT (n=4432). The mean change in lumbar spine BMD Z-score from baseline to Month 24 was 1.3 in the alendronate sodium-treated patients and 0.1 in the placebo-treated patients. Do not take 2 doses on the same day.If you take too much alendronate sodium, call your doctor. Therefore, instruct patients to wait at least one-half hour after taking alendronate sodium before taking any other oral medications.In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of alendronate sodium greater than 10 mg and aspirin-containing products.Alendronate sodium may be administered to patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). Discontinue Alendronate sodium when pregnancy is recognized.In animal reproduction studies, daily oral administration of alendronate to rats from before mating through the end of gestation or lactation showed decreased postimplantation survival and decreased pup body weight gain starting at doses equivalent to less than half of the highest recommended 40 mg clinical daily dose (based on body surface area, mg/m Fracture Intervention Trial: Three-Year Study (patients with at least one baseline radiographic vertebral fracture)Table 6: Effect of Alendronate Sodium on Fracture Incidence in the Three-Year Study of FIT (patients with vertebral fracture at baseline)Figure 1: Hip fractures, in particular, are associated with substantial morbidity, disability, and mortality.Daily oral doses of alendronate (5, 20, and 40 mg for six weeks) in postmenopausal women produced biochemical changes indicative of dose-dependent inhibition of bone resorption, including decreases in urinary calcium and urinary markers of bone collagen degradation (such as deoxypyridinoline and crosslinked N-telopeptides of type I collagen). This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.Things to remember when you fill your prescription.WebMD does not provide medical advice, diagnosis or treatment.This survey is being conducted by the WebMD marketing sciences department.All information will be used in a manner consistent with the WebMD
Patients with pre-existing gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs were included in these clinical trials. After swallowing alendronate sodium tablet, USP, wait at least 30 minutes:Before you lie down. ]1.2 Prevention of Osteoporosis in Postmenopausal WomenAlendronate sodium tablets, USP are indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies (14.2)]1.3 Treatment to Increase Bone Mass in Men with OsteoporosisAlendronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)].1.4 Treatment of Glucocorticoid-Induced OsteoporosisAlendronate sodium tablets, USP are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see Clinical Studies (14.4)].Alendronate sodium tablets, USP are indicated for the treatment of Paget's disease of bone in men and women. PHARMACIST: Dispense the enclosed Medication Guide to No dosage adjustment is necessary [see Clinical Pharmacology (12.3)].Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg (3256 mg/m2) and 966 mg/kg (2898 mg/m2), respectively. There may be new information.
In contrast, alendronate sodium 5 mg/day prevented bone loss in the majority of patients and induced significant increases in mean bone mass at each of these sites (see Figure 4). Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems.Instruct patients that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking alendronate sodium and consult their physician.If patients miss a dose of once weekly alendronate sodium tablet, instruct patients to take one dose on the morning after they remember.