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
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 436
- Locations
- 1
- Primary Endpoint
- Number of New Osteoporotic Fractures
Study Overview
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 patients at high fracture risk compared to a therapy-free interval?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Alendronate
Intervention: Alendronate (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of New Osteoporotic Fractures
Time Frame: From baseline to study termination (mean duration 5.6 months)
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.
Secondary Outcomes
- Combination of New Osteoporotic Fractures and Deaths(From baseline to study termination (mean duration 5.6 months))
- Mortality(From baseline to study termination (mean duration 5.6 months))
Investigators
Prof. Dr. med. Johannes Pfeilschifter
Head of Department of Internal Medicine III
Evangelisches Krankenhaus Lutherhaus gGmbH