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

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Evangelisches Krankenhaus Lutherhaus gGmbH
• Collaborator: German Federal Ministry of Education and Research
• Treatments: Alendronate; Diphosphonates

Criteria

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