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Fosamax (Alendronate Sodium) - Summary

 
 



FOSAMAX SUMMARY

FOSAMAX 1 (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.

FOSAMAX is indicated for:

  • Treatment and prevention of osteoporosis in postmenopausal women

    For the treatment of osteoporosis, FOSAMAX increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture. (See CLINICAL PHARMACOLOGY, Pharmacodynamics.)

  • For the prevention of osteoporosis, FOSAMAX may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture.

    Bone loss is particularly rapid in postmenopausal women younger than age 60. Risk factors often associated with the development of postmenopausal osteoporosis include early menopause; moderately low bone mass (for example, at least 1 standard deviation below the mean for healthy young adult women); thin body build; Caucasian or Asian race; and family history of osteoporosis. The presence of such risk factors may be important when considering the use of FOSAMAX for prevention of osteoporosis.

  • Treatment to increase bone mass in men with osteoporosis

  • 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 PRECAUTIONS, Glucocorticoid-induced osteoporosis). Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

  • Treatment of Paget's disease of bone in men and women

      Treatment is indicated in patients with Paget's disease of bone having alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.

    See all Fosamax indications & dosage >>

  • NEWS HIGHLIGHTS

    Published Studies Related to Fosamax (Alendronate)

    A randomized, double blind, placebo-controlled trial of alendronate treatment for fibrous dysplasia of bone. [2014]
    OBJECTIVE: To determine the efficacy of alendronate for treatment of FD... CONCLUSIONS: Alendronate treatment led to a reduction in the bone resorption

    Targeted anti-inflammatory systemic therapy for restenosis: The Biorest Liposomal Alendronate with Stenting sTudy (BLAST)-a double blind, randomized clinical trial. [2013]
    circulating monocyte levels, diabetes mellitus, and acute coronary syndrome... CONCLUSIONS: Intravenous administration of LABR-312 to patients undergoing

    Comparing tolerability and efficacy of generic versus brand alendronate: a randomized clinical study in postmenopausal women with a recent fracture. [2013]
    alendronate... CONCLUSIONS: Bone turnover markers were significantly reduced with branded and

    Effects of adding alendronate to ongoing hormone therapy on bone mineral density in postmenopausal Korean women: a randomized, double-blind, placebo-controlled clinical trial. [2013]
    density (BMD) in postmenopausal Korean women... CONCLUSIONS: Compared with HT alone, the addition of ALEN to ongoing HT for 1

    Targeted anti-inflammatory systemic therapy for restenosis: the Biorest Liposomal Alendronate with Stenting sTudy (BLAST)-a double blind, randomized clinical trial. [2013]
    circulating monocyte levels, diabetes mellitus, and acute coronary syndrome... CONCLUSIONS: Intravenous administration of LABR-312 to patients undergoing

    more studies >>

    Clinical Trials Related to Fosamax (Alendronate)

    FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267) [Completed]
    This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of FOSAMAX PLUS / FOSAMAX PLUS D through collecting the safety information according to the Re-examination Regulation for New Drugs. Note: FOSAMAX PLUS D is known as FOSAMAX PLUS in several markets. FOSAMAX PLUS (70 mg/2800 IU) and FOSAMAX PLUS D (70 mg/5600 IU).

    The Effects of Alendronate After Cure of Primary Hyperparathyroidism [Withdrawn]
    We are investigating whether, after surgical cure of primary hyperparathyroidism, alendronate provides even greater beneficial skeletal effects than parathyroidectomy alone. Primary Hyperparathyroidism (PHPT) is a disorder that can be associated with bone loss. After successful surgery for PHPT bone density improves without any treatment. However, it is possible that bone density might improve to an even greater extent if Fosamax is used after the surgical cure. Fosamax is approved by the FDA for the prevention and treatment of osteoporosis, and the goal of this project is to determine whether after successful surgical cure of PHPT, Fosamax is even better for the skeleton than just parathyroid surgery alone.

    Pilot Study of Fosamax in Spinal Cord Injury [Terminated]
    Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry (DEXA) scan every 6 months. Patients will complete 3 visits, screening, 6 months, 12 months and be required to take oral fosamax versus placebo weekly.

    Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions [Completed]

    Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury Previously Treated With Teriparatide [Enrolling by invitation]
    The purpose of this study is to determine if a year of alendronate treatment will maintain or increase bone mass density (BMD) compared to baseline BMD values in people with chronic SCI. This study will also investigate 1) if alendronate therapy will increase bone strength in people with chronic SCI, 2) the safety of alendronate, and 3) the effects of alendronate on serum markers of bone metabolism.

    more trials >>

    Reports of Suspected Fosamax (Alendronate) Side Effects

    Femur Fracture (7166)Fall (3619)LOW Turnover Osteopathy (3137)Osteoarthritis (2671)Hypertension (2142)Tooth Disorder (1925)Anxiety (1869)Gastrooesophageal Reflux Disease (1770)Arthralgia (1697)Depression (1655)more >>


    PATIENT REVIEWS / RATINGS / COMMENTS

    Based on a total of 20 ratings/reviews, Fosamax has an overall score of 4.40. The effectiveness score is 4.90 and the side effect score is 6.40. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
     

    Fosamax review by 63 year old female patient

      Rating
    Overall rating:  
    Effectiveness:   Highly Effective
    Side effects:   No Side Effects
      
    Treatment Info
    Condition / reason:   osteoporosis
    Dosage & duration:   70 mg taken once/week for the period of ongoing
    Other conditions:   high cholesterol
    Other drugs taken:   none
      
    Reported Results
    Benefits:   Reduce the osteoporosis
    Side effects:   None
    Comments:   Take one pill each week, the first thing in t he morning, You must be able to stay up for at least 30 minutes after taking the pill, and you cannot eat or drink anything besides water within 30 minutes of taking a pill, and then you must eat before lying down.

     

    Fosamax review by 54 year old female patient

      Rating
    Overall rating:  
    Effectiveness:   Moderately Effective
    Side effects:   Moderate Side Effects
      
    Treatment Info
    Condition / reason:   Osteopenia in both hips and lower back
    Dosage & duration:   70 mg? iu? per week taken once a week for the period of 7 months
    Other conditions:   IBS, Mild depression
    Other drugs taken:   Zoloft
      
    Reported Results
    Benefits:   Slight increase in bone density in hips, however no change in back (vertabrae)
    Side effects:   After taking the drug for 7 months, I literally developed severe gastric reflux one evening (June 2007). Actual acid reflux disappeared within a few days, but symptoms feeling like a hard, sometimes painful lump in my esophagus persisted for months, especially when lying down. Even after giving up Fosamax 2 months after initial symptoms occurred (in Sept '07, the condition persisted.
    Comments:   I was sent by my general practitioner for an endoscopy 3 months (Dec '07) after giving up Fosamax, results of which showed irritation of end of esophagus tube where it joins my stomach. I was prescribed Nexium for the condition, and after taking for 3-4 months, the symptoms finally disappeared. I would NEVER take Fosamax or any alendronate based or similar drug again.

     

    Fosamax review by 69 year old female patient

      Rating
    Overall rating:  
    Effectiveness:   Marginally Effective
    Side effects:   Severe Side Effects
      
    Treatment Info
    Condition / reason:   loss of bone density in spine
    Dosage & duration:   70 mg taken weekly for the period of 2 years
    Other conditions:   none
    Other drugs taken:   simvastatin 20mg daily
      
    Reported Results
    Benefits:   bone scan showed no increase bone loss.
    Side effects:   mild at first,slight headache,jaw pain,some stiffness in joints.thought that it was drug related,but could tolerate it if it was working.than this spring,started to have increasing pain and swelling ,knees,fingers,trouble lifting up arms.at some point i realized that this was getting serious
    Comments:   i stopped taking the medication and i am improving.i have been off medication about 5 weeks now.aspirin only 325 mg 2-3 tabs a day has helped me along with mild frequent exercise

    See all Fosamax reviews / ratings >>

    Page last updated: 2015-08-10

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