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

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

Detailed Description
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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?

Official Title
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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

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Alendronate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alendronate<br> | Drug: Alendronate<br>* 70 mg per week<br>* Other names: Fosamax;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 pill per week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of New Osteoporotic Fractures | 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. | From baseline to study termination (mean duration 5.6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Number of deaths | From baseline to study termination (mean duration 5.6 months) | 
| Combination of New Osteoporotic Fractures and Deaths | Number of participants with a new osteoporotic fracture or death | From baseline to study termination (mean duration 5.6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Osteoporotic fractures, Bisphosphonate, Pretreatment with bisphosphonates