Original ArticleTolerability of Once-Weekly Alendronate in Patients With Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Study
Section snippets
PATIENTS AND METHODS
This multicenter, randomized, double-blind, placebo-controlled study was conducted at 48 outpatient study centers in the United States. The first patient initiated treatment June 5, 2000, and the last patient completed treatment March 1, 2001. A total of 498 ambulatory community-dwelling postmenopausal women and men with osteoporosis, as determined by individual investigators (by bone mass measurement or clinical diagnosis), were evaluated for inclusion in the study. There were no prespecified
RESULTS
Among the 450 patients randomized, 419 (93%) completed the study (Figure 1). Patient characteristics in both treatment groups were similar at baseline (Table 1). Seventy-seven percent of all patients had taken prior antiresorptive medications (171 in the alendronate group and 174 in the placebo group). There were 212 patients with prior bisphosphonate exposure (112 [50%] in the alendronate group and 100 [44%] in the placebo group). Approximately 15% of the patients (37 in the alendronate group
DISCUSSION
Osteoporosis is a chronic disease that typically requires long-term therapy to increase patients’ BMD and prevent the occurrence of fractures.23, 24, 25, 26, 27 Both the 10-mg/d and 70-mg once-weekly formulations of alendronate have shown comparable efficacy in increasing BMD in women with osteoporosis.20 Although symptoms referable to the upper GI tract are commonly reported in patients taking oral bisphosphonates, they are also common among postmenopausal women in general.28 The present study
CONCLUSION
In this 3-month study, the incidence of upper GI tract adverse events and the incidence of treatment discontinuation due to drug-related upper GI tract adverse events did not differ significantly in patients receiving once-weekly alendronate, 70 mg, and those receiving placebo. The overall incidence of adverse events was similar in both treatment groups. Similar results were observed in subsets of patients with and without prior exposure to bisphosphonates. Once-weekly alendronate had a
Acknowledgments
We acknowledge the dedication and expertise demonstrated by the study coordinators at the investigative sites: John Abruzzo, MD, Thomas Jefferson University Osteoporosis Center, Philadelphia, Pa; Neil Binkley, MD, University of Wisconsin-Madison; Martin Blidner, MD, Arthritis Center of Northeast Pennsylvania, Inc, Wilkes Barre; Henry Bone, MD, Michigan Bone and Mineral Clinic, PC, Detroit; Stephen Bookbinder, MD, Ocala Rheumatology Research Center, Ocala, Fla; Jacques Caldwell, MD, Halifax
REFERENCES (31)
- et al.
Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures
Lancet
(1996) - et al.
Weekly administration of alendronate: rationale and plan for clinical assessment
Clin Ther
(2000) Treatment of osteoporosis with bisphosphonates
Rheum Dis Clin North Am
(2001)- et al.
Endoscopic comparison of esophageal and gastroduodenal effects of risedronate and alendronate in postmenopausal women
Gastroenterology
(2000) - et al.
Upper gastrointestinal toxicity of alendronate
Am J Gastroenterol
(2000) - et al.
The upper GI safety and tolerability of oral alendronate at a dose of 70 milligrams once weekly: a placebo-controlled endoscopy study
Am J Gastroenterol
(2002) - et al.
Administration routes and delivery systems of bisphosphonates for the treatment of bone resorption
Adv Drug Deliv Rev
(2000) - et al.
Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota
Gastroenterology
(1997) - et al.
Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis
N Engl J Med
(1995) - et al.
Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial
JAMA
(1998)
Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: results of the FOSIT study
Osteoporos Int
Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial [[published correction appears in J Clin Endocrinol Metab. 2001;86:938]
J Clin Endocrinol Metab
Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis
N Engl J Med
The clinical tolerability profile of alendronate
Int J Clin Pract
A medication use evaluation of alendronate: compliance with administration guidelines
Pharm Pract Manag Q
Cited by (0)
Funding from Merck & Co, Inc, West Point, Pa, supported this work.
- 1
Dr Greenspan is a researcher, speaker, and consultant for Merck & Co, Inc; a researcher, speaker, and consultant for Eli Lilly and Company; and a speaker for Procter & Gamble.
- 2
Dr Field-Munves is a consultant for Merck & Co, Inc, Aventis, and Eli Lilly and Company; a speaker for Merck & Co, Inc, Aventis, and Eli Lilly and Company; and has received grants and research support from Merck & Co, Inc.
- 3
Dr Tonino is a speaker, researcher, and consultant for Merck & Co, Inc, and a consultant and speaker for Procter & Gamble. Drs Petruschke, Wang, Yates, de Papp, and Palmisano and Ms Smith are employees of Merck & Co, Inc.