Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy (BILANZ)
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ClinicalTrials.gov Identifier: NCT01512446
Recruitment Status :
(low recruitment rate)
The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
Condition or disease
Drug: AlendronateDrug: Placebo
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?
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Ages Eligible for Study:
60 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Postmenopausal women or men > 60 years
DXA T-Score at lumbar spine, total hip or femur neck <-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy
Pretreatment with bisphosphonates for at least four years
Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009
Signed informed consent
Other pharmacological treatment of osteoporosis during the last 48 months
Other bone diseases
Renal insufficiency with a calculated creatinine clearance < 35 ml/min
Diseases of the esophagus, delayed esophageal clearance