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
Overview
The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: March 2013
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?
Interventions
- Drug: Alendronate
- 70 mg per week
- Drug: Placebo
- 1 pill per week
Arms, Groups and Cohorts
- Active Comparator: Alendronate
- Placebo Comparator: Placebo
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- Mortality
- Time Frame: From baseline to study termination (mean duration 5.6 months)
- Number of deaths
- Combination of New Osteoporotic Fractures and Deaths
- Time Frame: From baseline to study termination (mean duration 5.6 months)
- Number of participants with a new osteoporotic fracture or death
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 60 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Evangelisches Krankenhaus Lutherhaus gGmbH
- Collaborator
- German Federal Ministry of Education and Research
- Provider of Information About this Clinical Study
- Principal Investigator: Prof. Dr. med. Johannes Pfeilschifter, Head of Department of Internal Medicine III – Evangelisches Krankenhaus Lutherhaus gGmbH
- Overall Official(s)
- Johannes Pfeilschifter, Prof. Dr. med., Study Director, Alfried Krupp Krankenhaus Essen Steele
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