Esophagitis Associated with the Use of Alendronate

Groen, Piet C. de; Lübbe, D; Hirsch, Laurence; Daifotis, Anastasia G.; Stephenson, Wendy P.; Freedholm, Debra; Pryor-Tillotson, S.; Seleznick, Mitchel J.; Pinkas, Haim; Wang, Kenneth K.

doi:10.1056/nejm199610033351403

Cited by 696 publications

(326 citation statements)

References 12 publications

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“…Gastrointestinal complaints were the main type of adverse event reported. Alendronate has been associated with potentially severe adverse esophageal effects 41,42 in approximately 1.3% of patients. 43 To decrease the likelihood of esophageal side effects, a formulation of 70 mg alendronate once weekly was selected for use.…”

Section: Discussionmentioning

confidence: 99%

Alendronate Improves Bone Mineral Density in Primary Biliary Cirrhosis: A Randomized Placebo-Controlled Trial * #

et al. 2005

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Bone loss is a well-recognized complication of primary biliary cirrhosis (PBC). Although it has been suggested that alendronate might improve bone mineral density (BMD) in PBC, no randomized placebo-controlled trial has been conducted. The primary aim of this study was to compare the effects of alendronate versus placebo on BMD and biochemical measurements of bone turnover in patients with PBC-associated bone loss. We conducted a doubleblinded, randomized, placebo-controlled trial. Patients with a PBC and BMD t score of less than ؊1.5 were randomized to receive 70 mg per week of alendronate or placebo over 1 year. BMD of the lumbar spine and proximal femur were measured at entry and at 1 year. Changes from baseline in BMD and biochemical measurements of bone turnover were assessed. Thirty-four patients were enrolled. Seventeen patients were randomized to each arm. After 1 year, a significantly larger improvement (P ‫؍‬ .005) in spine BMD was observed in the alendronate group (0.09 ؎ 0.03 g/cm 2 SD from baseline) compared with the placebo group (؊0.003 ؎ 0.02 g/cm 2 SD from baseline). A larger improvement (P ‫؍‬ .046) was also observed in the femoral BMD of alendronate patients versus placebo. BMD changes were independent of concomitant estrogen therapy. The rate of adverse effects was similar in both groups. In conclusion, in patients with PBC-related bone loss, alendronate significantly improves BMD compared with placebo. Although in this study oral alendronate appears to be well tolerated in patients with PBC, larger studies are needed to formally evaluate safety.

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Section: Discussionmentioning

confidence: 99%

Alendronate Improves Bone Mineral Density in Primary Biliary Cirrhosis: A Randomized Placebo-Controlled Trial * #

et al. 2005

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“…The more notable adverse effects of bisphosphonates include hiatal hernias, dyspepsia, osteonecrosis of the jaw, and a newly defined class of characteristic low-energy subtrochanteric fractures. Gastrointestinal side effects are well documented in women, although they are also seen in men but at an unclear ratio regarding disease incidence in each sex [12]. Osteonecrosis of the jaw is an exceptional rare entity without sex specificity [41].…”

Section: Medication Response and Adherencementioning

confidence: 99%

Sex and Gender Considerations in Male Patients With Osteoporosis

LaMont

Ton

et al. 2011

Clinical Orthopaedics &Amp; Related Research

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Background Osteoporosis remains underrecognized and undertreated in both men and women, but men who sustain fragility fractures experience greater morbidity and mortality. While men exhibit advanced comorbidity at the time of hip fracture presentation, there are distinct sex-and gender-specific factors related to the pathophysiology and treatment of osteoporosis that further influence morbidity and mortality. Questions/purposes With a selective review of the literature, we evaluated sex-and gender-based differences contributing to increased morbidity and mortality in men with osteoporosis.

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“…There exists some evidence that branded Risedronate might be a slightly better suitable alternative bisphosphonate drug for gastrointestinal sensitive patients compared to original branded or generic Alendronate [7][8][9]32,33,[39][40][41][42][43][44][45][46]. Two recent studies have shown differences in tablets properties that might explain different rates of adverse events.…”

Section: Lower Bioavailability and Higher Rate Of Adverse Events Due mentioning

confidence: 99%

Differences in persistence, safety and efficacy of generic and original branded once weekly bisphosphonates in patients with postmenopausal osteoporosis: 1-year results of a retrospective patient chart review analysis

Ringe

Möller

2009

Rheumatol Int

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Esophagitis Associated with the Use of Alendronate

Cited by 696 publications

References 12 publications

Alendronate Improves Bone Mineral Density in Primary Biliary Cirrhosis: A Randomized Placebo-Controlled Trial * #

Alendronate Improves Bone Mineral Density in Primary Biliary Cirrhosis: A Randomized Placebo-Controlled Trial * #

Sex and Gender Considerations in Male Patients With Osteoporosis

Differences in persistence, safety and efficacy of generic and original branded once weekly bisphosphonates in patients with postmenopausal osteoporosis: 1-year results of a retrospective patient chart review analysis

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