The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
436
70 mg per week
1 pill per week
Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele
Essen, Germany
Number of New Osteoporotic Fractures
Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes.
Time frame: From baseline to study termination (mean duration 5.6 months)
Mortality
Number of deaths
Time frame: From baseline to study termination (mean duration 5.6 months)
Combination of New Osteoporotic Fractures and Deaths
Number of participants with a new osteoporotic fracture or death
Time frame: From baseline to study termination (mean duration 5.6 months)
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