Alendronate (Alendronate Sodium) - Summary

ALENDRONATE SUMMARY

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.

Alendronate sodium tablets are indicated for: 
 

• Treatment and prevention of osteoporosis in postmenopausal women 
  For the treatment of osteoporosis, alendronate sodium tablets increases bone mass and reduce 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, alendronate sodium tablets 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.

• 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.

NEWS HIGHLIGHTS

Published Studies Related to 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)...

more studies >>

Clinical Trials Related to 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.

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]

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.

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

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.