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Alendronate (Alendronate Sodium) - Summary

 
 



ALENDRONATE SUMMARY

Alendronate Sodium is bisphosphonate that acts as a specific inhibitor of osteoclastmediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.

Treatment of Osteoporosis in Postmenopausal Women

Alendronate Sodium Tablet is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women,  Alendronate Sodium Tablet increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies].

Prevention of Osteoporosis in Postmenopausal Women

Alendronate Sodium Tablet is indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies].

Treatment to Increase Bone Mass in Men with Osteoporosis

Alendronate Sodium Tablet is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies].

Treatment of Glucocorticoid-Induced Osteoporosis

Alendronate Sodium Tablet is 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].

Treatment of Paget's Disease of Bone

Alendronate Sodium Tablet is indicated for the treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget’s disease of bone who have 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 Clinical Studies].

Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of Alendronate Sodium for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.


See all Alendronate indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to 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 Alendronate

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.

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.

Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss [Not yet recruiting]
Antiretroviral therapy (ART) initiation is associated with a significant loss of bone mineral density (BMD), characterised by increases in bone turnover, which is largely limited to the first 48 weeks of therapy. Bisphosphonates, such as alendronate, decrease bone turnover and can limit loss of bone mineral density. This study aims to determine if a short course of treatment with the oral bisphosphonate alendronate can limit loss of bone mineral density associated with initiation of ART in HIV-1 infected, antiretroviral naive, adult subjects.

Alendronate Compared to Metformin in Chronic Periodontitis [Completed]

Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients [Completed]
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.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Alendronate has an overall score of 5.50. The effectiveness score is 5.50 and the side effect score is 6.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Alendronate review by 49 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   osteopenia
Dosage & duration:   1 tab per week taken once a week for the period of 2years and ongoing
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Increased bone density by 11% first year.
Side effects:   Mild stomach discomfort.
Comments:   Once a week Fosomax, taken on empty stomach with plenty of water. Ability to stand or sit upright for at least 30 minutes after taking is required. My phyisican prefers this to once a month options, saying it is more effective.

 

Alendronate review by 61 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   osteoporosis
Dosage & duration:   1 tablet weekly 70 mg taken once a week for the period of one year approximately
Other conditions:   mild depression
Other drugs taken:   effexor
  
Reported Results
Benefits:   No benefits that I can see. My doctor said it was not useful to do another bone scan to see if there had been a change in a year so I have no idea if there was any benefit. I have been experiencing fairly severe leg pains for the past year and could not find out what they were from. Did numerous tests, no results. Then I saw on the insert that side effects could be muscle, bone or joint pain and when I read a comment on here describing dull aching in one leg in particular radiating down from the hip and below the knee. I thought...that is me!!! So I am stopping this drug and waiting to see what happens with the new aches and pains. Maybe it is this drug. I hope so.
Side effects:   See above.
Comments:   Took alendronate for osteoporosis for over a year.

 

Alendronate review by 61 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   osteoporosis
Dosage & duration:   1 tablet weekly 70 mg taken once a week for the period of one year approximately
Other conditions:   mild depression
Other drugs taken:   effexor
  
Reported Results
Benefits:   No benefits that I can see. My doctor said it was not useful to do another bone scan to see if there had been a change in a year so I have no idea if there was any benefit. I have been experiencing fairly severe leg pains for the past year and could not find out what they were from. Did numerous tests, no results. Then I saw on the insert that side effects could be muscle, bone or joint pain and when I read a comment on here describing dull aching in one leg in particular radiating down from the hip and below the knee. I thought...that is me!!! So I am stopping this drug and waiting to see what happens with the new aches and pains. Maybe it is this drug. I hope so.
Side effects:   See above.
Comments:   Took alendronate for osteoporosis for over a year.

See all Alendronate reviews / ratings >>

Page last updated: 2015-08-10

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