Status:
TERMINATED
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
Lead Sponsor:
Evangelisches Krankenhaus Lutherhaus gGmbH
Collaborating Sponsors:
German Federal Ministry of Education and Research
Conditions:
Osteoporosis
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
Detailed Description
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT01512446
Start Date
February 1 2012
End Date
March 1 2013
Last Update
February 12 2019
Active Locations (1)
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1
Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele
Essen, Germany, 45276