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

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

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?

Inclusion Criteria:

• 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

Exclusion Criteria:

• Other pharmacological treatment of osteoporosis during the last 48 months
• Other bone diseases
• Malabsorption syndromes
• Renal insufficiency with a calculated creatinine clearance < 35 ml/min
• Diseases of the esophagus, delayed esophageal clearance
• UUnability to realise the intake instructions
• Hypocalcemia