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 indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Fosamax (Alendronate)

Teriparatide Outperforms Alendronate In Treating Steroid-Induced Osteoporosis
Source: Arthritis / Rheumatology News From Medical News Today [2009.10.30]
A recent study determined glucocorticoid-induced osteoporosis (OP) is now treatable with Teriparatide, a synthetic form of the human parathyroid hormone. Researchers found patients with glucocorticoid-induced OP who were treated with teriparatide for 36 months had a greater increase in bone mineral density (BMD) and fewer new vertebral fractures than those treated with alendronate.

Better Drug Emerges for Steroid-Induced Bone Loss (HealthDay)
Source: Y! Health Bones, Joints & Muscles News [2009.10.29]
HealthDay - THURSDAY, Oct. 29 (HealthDay News) -- The drug teriparatide is better at increasing bone density and reducing vertebral fractures in patients with glucocorticoid-induced osteoporosis than the drug alendronate, a new study finds.

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Published Studies Related to Fosamax (Alendronate)

Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial. [2009.08]
OBJECTIVE: Glucocorticoid-induced osteoporosis is the most common iatrogenic form of osteoporosis. We evaluated the efficacy and safety of once-weekly bisphosphonate therapy for prevention and treatment of bone loss in patients on glucocorticoid therapy... CONCLUSION: Over 12 months ALN OW significantly increased lumbar spine, trochanter, total hip, and total body BMD compared with baseline among patients taking glucocorticoid therapy. A significant treatment difference versus placebo was observed at 12 months for the mean percentage change from baseline for lumbar spine, trochanter, and total hip.

A double-blinded head-to-head trial of minodronate and alendronate in women with postmenopausal osteoporosis. [2009.06]
INTRODUCTION: In a randomized, active-controlled, double-blinded, multicenter study, the efficacy and safety of minodronate were examined and compared to that of alendronate... CONCLUSIONS: The effects on lumbar and hip BMD and the safety profile of minodronate are comparable to those of alendronate. Minodronate is a promising new potent bisphosphonate for the treatment of osteoporosis.

Retreatment with teriparatide one year after the first teriparatide course in patients on continued long-term alendronate. [2009.06]
Patients treated with teriparatide after prior and ongoing alendronate therapy experience spine BMD increases; however, some continue to be at high risk for fracture, based on persistently low BMD and/or fracture history. The objective of this study was to determine whether a second discrete retreatment course with teriparatide could produce similar biochemical and BMD changes as seen during the first teriparatide course...

Bioavailability and bioequivalence of two oral formulations of alendronate sodium 70 mg: an open-label, randomized, two-period crossover comparison in healthy Korean adult male volunteers. [2009.05]
BACKGROUND: Alendronate sodium is a Bisphosphonate drug used to treat and prevent osteoporosis and several other bone diseases. A new formulation has been developed and is currently awaiting regulatory approval, pending findings on bioequivalence. OBJECTIVES: The aims of the present study were to compare the bioavailability and pharmacokinetic (PK) properties, and to determine the bioequivalence, of a test and reference formulation of alendronate sodium 70 mg in a healthy Korean adult male population... CONCLUSIONS: Single doses of these formulations of alendronate sodium 70 mg met the criteria for bio-equivalence. No statistically significant differences in AUC(0-t), AUC(0-infinity), and C(max) were found in this healthy Korean adult male population.

Alendronate and indapamide alone or in combination in the management of hypercalciuria associated with osteoporosis: a randomized controlled trial of two drugs and three treatments. [2009.05]
BACKGROUND: The role of bisphosphonates (BPs) in the management of patients with hypercalciuria (HC) associated with osteoporosis is still uncertain. The aim of the study was to evaluate the effect of alendronate and indapamide alone or in combination on bone mineral density (BMD) and 24-h urinary calcium excretion (24-CaU) in post-menopausal women with HC and low BMD... CONCLUSIONS: These results show a benefit, in terms of BMD improvement and 24-CaU reduction, associated with BPs' therapy in combination with indapamide in HC associated with osteoporosis. The combination therapy demonstrated a reduction of 24-CaU and an increase in LS BMD superior to that observed with alendronate alone. Our results support a new potential approach with BPs associated with thiazide diuretics or indapamide in the management of post-menopausal women with HC and associated bone loss. Studies on the larger sample size are needed to demonstrate the efficacy on the fracture outcome.

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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.

Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss [Completed]
This is a study to determine if Fosamax (alendronate), a medication approved by the Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in postmenopausal women, is effective in decreasing the rate of bone loss which often begins to increase in the three to five years preceding the menopause (perimenopausal transition).

During the three to five years prior to the menopause, the rate of bone loss increases. One way that physicians treat this is with oral contraceptive medication. However, the incidence of complications from oral contraceptives after the age of 40 increases. Therefore, a non-hormonal means of preventing bone loss should be useful. Fosamax (alendronate) is in a class of compounds called bisphosphonates. This study is being done to determine whether Fosamax can be used to prevent the increased rate of bone loss during the perimenopausal transition.

Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients [Active, not recruiting]
The primary objective of this study is to determine efficacy of 70 mg alendronate once weekly compared to placebo. This will be measured by percent changes in lumbar spine(LS) bone mineral density(BMD) in adult cystic fibrosis(CF)patients after one year of treatment. The investigators hypothesize that in adult CF patients with osteopenia or osteoporosis, alendronate 70 mg once weekly will produce a mean increase from baseline in lumbar spine BMD that is greater than that observed with placebo at 12 months.

Pharmacokinetics of a Single 14C-Labeled Dose of Risedronate or Alendronate Followed by Once-a-Week Unlabeled Oral Dose [Completed]

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PATIENT REVIEWS / RATINGS / COMMENTS

Fosamax review by 52 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		bone loss
Dosage & duration:		70mg taken weekly for the period of 7 years
Other conditions:		none
Other drugs taken:		multi vitamins
		Reported Results
Benefits:		Helped build bone loss. Osteoporsis runs in my family. We are thin. Two of my sisters were diagnosed with osteoporsis in their early 40s. One sister fractured her pelvic bone at 40 from bone loss.
Side effects:		I had no side effects. I always followed the directions - take it with water. No other foods or drinks for an hour afterward. Don't ly down.
Comments:		I took the drug weekly for about 8 years. During that time I have had 3 bone scans. My bone loss subsided. I also drink a lot of diet soda though, and that can effect calcium intake. In the last year I have increased exercising with weights. I am due for another bone scan in the fall.

Fosamax review by 45 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		osteoporosis
Dosage & duration:		70mg taken once a week for the period of 3 1/2 years +
Other conditions:		none
Other drugs taken:		e-string (estradiol vaginal ring)
		Reported Results
Benefits:		in theory, my bones should have gotten stronger, as measured by the bone scan done at my gynecologist office once every 18 months
Side effects:		I first tried the tablets and they would sit on my stomach as if I had a brick for breakfast. So I tried the oral solution which, in fact, was better on the stomach but,still, not completely without side effects. Most of the days I took Fosamax I had a slight stomach discomfort during the morning.
Comments:		I took Fosamax for almost 4 years and after 2 bone density scans which showed no improvement I decided to stop the treatment, against my doctor advice which was to take Fosamax for at least 5 years. I believe that we still do not know enough about how the bone keeps itself healthy and that bone scans are not yet reliable. It's a big business and I finally refused to keep a medication that is so hard on the digestive system and can also have very dangerous side effects (frozen bones, I believe it is called). I still have to be convinced that a low density bone is not necessarily stronger than a bone with more density. Waiting for more research I am trying to walk as much as possible and to follow a reasonable diet. And to be at peace with myself... Thanks!

Fosamax review by medical professional caring for 61 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		osteoprosis
Dosage & duration:		70 mg taken one dose for the period of once
Other conditions:		n/a
Other drugs taken:		n/a
		Reported Results
Benefits:		one dose don't know
Side effects:		I took one dose on a Friday and that night I had such bad rib and breast bone pain I thought I had strained a muscle. Today is the fourth day and still in pain. The pain is moving to my back, sides and then back to chest. Today is the fourth day with this pain and seems to getting better. I am not going to take this drug any more.
Comments:		one pill once a week