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

Media Articles Related to 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 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 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]

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.

Evaluation Of Missed Osteoporosis Diagnoses, And Preference Between Once Monthly Ibandronate And Once Weekly Alendronate [Completed]
This is a two part study (screening and treatment). The first part (screening) is designed to evaluate the percentage of patients missed in diagnosing osteoporosis by general practitioners (GP's). The second part (treatment) is designed to determine the preference by patients for the once monthly ibandronate or the once weekly alendronate.

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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 62 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		osteopenia
Dosage & duration:		70 mg taken 1/wk for the period of 4 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I have taken this drug for four years, with a hiatus of about 1 year because I was afraid of dire side affects that had been widely advertised, having to do with the deterioration of jaw bone. The alendronate did not seem to stop the slow progression of my osteopenia, as measured by yearly bone density scans. I tried a regular exercise program, using a vibration machine (powerplate) and that stopped the progression of my osteopenia. I stopped the alendronate medication, thinking the exercise was more helpful and I was afraid of side effects. However, the exercise alone did not work. I have re-started the alendronate medication and am hoping that the combination of the medication and exercise will help.
Side effects:		I have a bad taste in my mouth the day I take the alendronate medication and worry about side-affects, including long-term side affects which are undetectable currently.
Comments:		I take the medication 1/wk. I also run or walk daily.