Fosamax (Alendronate Sodium) - Summary

FOSAMAX SUMMARY

Patient Information

FOSAMAX (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)

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

Alendronate and atrial fibrillation: a meta-analysis of randomized placebo-controlled clinical trials. [2012]
other cardiovascular endpoints in clinical trials of alendronate... CONCLUSIONS: The incidence of atrial fibrillation was low in Merck clinical

Prevention of Glucocorticoid-Induced Osteoporosis in Immunobullous Diseases With Alendronate: A Randomized, Double-blind, Placebo-Controlled Study. [2011.11.21]
OBJECTIVE: To evaluate the efficacy and safety of oral alendronate sodium therapy once daily in preventing glucocorticoid-induced bone loss in patients with immunobullous skin diseases treated with long-term glucocorticoid therapy... CONCLUSIONS: There were statistically significant increases in BMD at both the lumbar spine (P = .01) and the femoral neck (P = .01) with alendronate therapy. It is imperative to use bisphophonate therapy in patients with immunobullous disorders who are receiving oral corticosteroids because it largely prevents the morbidity associated with low BMD.

Alendronate is more effective than elcatonin in improving pain and quality of life in postmenopausal women with osteoporosis. [2011.10]
A randomized controlled trial was performed to compare the short-term effects of alendronate (ALN) and ECT on pain and quality of life (QOL) in postmenopausal women with osteoporosis. Back pain and QOL [Short-Form Health Survey (SF-8)] significantly improved at 1, 3, and 6 months in both groups, with greater improvements in the ALN group than in the ECT group. These results suggested that ALN reduced back pain and improved QOL more markedly than ECT in postmenopausal osteoporotic women with back pain. INTRODUCTION: Intramuscular ECT is known to reduce pain via the central nervous system. A multicenter randomized controlled trial was performed to compare the short-term effects of ALN and ECT on pain and QOL in postmenopausal women with osteoporosis... CONCLUSIONS: ALN suppressed bone turnover, reduced back pain, and improved QOL more markedly than ECT in postmenopausal osteoporotic women with back pain.

Effect of alendronate and vitamin D on fractional calcium absorption in a double-blind, randomized, placebo-controlled trial in postmenopausal osteoporotic women. [2011.08]
Menopause and increasing age are associated with a decrease in calcium absorption that can contribute to the pathogenesis of osteoporosis. We hypothesized that alendronate plus vitamin D(3) (ALN + D) would increase fractional calcium absorption (FCA)...

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Clinical Trials Related to Fosamax (Alendronate)

Parathyroid Hormone (PTH) With Alendronate for Osteoporosis [Completed]
This study investigates the effectiveness of parathyroid hormone (PTH) in combination with alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip. We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion. The entire study is 21 months long; the active treatment period is 18 months with a 6-month followup period.

The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We will randomly assign all study participants, who are women aged 50 and over, to either stay on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate.

Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis [Active, not recruiting]
We have previously evaluated the safety and efficacy of Fosamax in 10 patients with juvenile osteoporosis during a 12-month clinical trial. We have documented that Fosamax improved BMD of the spine and hip without any major side effects. There were no additional fractures during therapy. The present study is designed to further evaluate the safety and efficacy of Fosamax in 20 children with juvenile osteoporosis using a double-blind, randomized, placebo-controlled, cross-over protocol.

Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329) [Not yet recruiting]
This study will assess the effect of 26 weeks of once-weekly treatment with MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) on serum levels of 25-hydroxyvitamin D [25(OH)D].

Safety and Effectiveness of Oral Alendronate Therapy on Bone Mineral Density in HIV-infected Children and Adolescents With Low Bone Mineral Density [Recruiting]
HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be expected for HIV-uninfected people of similar age, weight and race. As the majority of perinatally HIV-infected U. S. children are entering or in adolescence, the potential for HIV-related impaired BMD during the adolescent peak of bone mass acquisition is of particular concern. The primary purpose of this study is to compare changes from pre-treatment levels of BMD of the lumbar spine after 24 and 48 weeks of alendronate treatment with placebo in HIV-infected children and adolescents.

Pilot Study of Fosamax in Spinal Cord Injury [Recruiting]
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.

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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

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