Binosto (Alendronate Sodium) - Summary

BINOSTO SUMMARY

BINOSTO (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.

Treatment of Osteoporosis in Postmenopausal Women

BINOSTO effervescent tablet 70 mg is indicated for the treatment of osteoporosis in postmenopausal women. For the treatment of osteoporosis, alendronate sodium increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies]

Treatment to Increase Bone Mass in Men With Osteoporosis

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

Important Limitations of Use

The safety and effectiveness of BINOSTO for the treatment of osteoporosis are based on clinical data of four years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.

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NEWS HIGHLIGHTS

Published Studies Related to Binosto (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

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Clinical Trials Related to Binosto (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.

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.

Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions [Completed]

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