Original researchTherapeutic equivalence of alendronate 35 milligrams once weekly and 5 milligrams daily in the prevention of postmenopausal osteoporosis
Section snippets
Materials and methods
To be eligible for the study, women had to be 40–70 years of age and postmenopausal, as diagnosed by a history of the absence of menstrual periods during the 6 months preceding randomization; for those women whose last menstrual period occurred 6–12 months before study start, serum follicle-stimulating hormone levels were confirmed to be in the reference range for postmenopausal women. Other entry criteria included bone mineral density T-score (standard deviation difference from the normal
Results
Women randomized to the two treatment groups had similar baseline characteristics in terms of age, years since menopause, body mass index, dietary calcium intake, prior vertebral fracture, history of upper gastrointestinal disease, and prior nonsteroidal antiinflammatory drugs or aspirin use (Table 1). Although women with radiologic fractures of the lumbar spine were excluded at screening based on local review of spine radiographs, small, comparable proportions of women enrolled in the two
Discussion
In two major studies employing daily regimens of alendronate enrolling a total of 2056 postmenopausal women without osteoporosis, treatment with alendronate 5 mg daily resulted in significant increases in lumbar spine bone mineral density (an average increase of 3% in the first year, which was maintained in subsequent years of treatment), as well as smaller yet significant increases in hip and total body bone mineral density. By contrast, the placebo groups experienced progressive bone loss at
Acknowledgements
The authors thank Marianne Daley and Christine Peverly for their outstanding contributions in overseeing the conduct of this trial, and Douglas Tracey and Andrea Dynder for expert data coordination and statistical programming support.
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Efficacy and safety of monthly oral ibandronate in the prevention of postmenopausal bone loss
2009, BoneCitation Excerpt :These data demonstrate that monthly ibandronate is effective in preventing bone loss at the LS and proximal femur in young postmenopausal women with low BMD. The average BMD decreased modestly in both the spine and proximal femur in the participants receiving only calcium and vitamin D (placebo group), as has been seen in other studies involving young postmenopausal women [8–13]. BMD increases of 1.1–3.7% were observed by DXA at the spine (adjusted for baseline LS BMD and time since menopause) and proximal femur sites after 12 months of therapy with monthly ibandronate.
Strategies for the prevention and treatment of osteoporosis during early postmenopause
2006, American Journal of Obstetrics and GynecologyCitation Excerpt :Importantly, BMD continues to increase at the lumbar spine and hip through 10 years of treatment.65 The once weekly, 35-mg dosage of alendronate has been shown to be equivalent to the once daily, 5-mg dosage in terms of BMD increases at the lumbar spine in early postmenopausal women (mean age: 56 years.)66 Risedronate has been shown to reduce the risk of vertebral and nonvertebral fractures early in the course of therapy (within 6 months of initiation) in postmenopausal women67,68 with sustained protection through up to 7 years of therapy in multiple, large clinical trials: Vertebral Efficacy with Risedronate Therapy–North America, Vertebral Efficacy with Risedronate Therapy–Multinational, and the Hip Intervention Program.36,38,40,69-71
Postmenopausal osteoporosis and alendronate
2004, Maturitas