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

Phase 3

Terminated

• Conditions: Osteoporosis
• Interventions: Drug: Placebo; Drug: Alendronate

• Registration Number: NCT01512446
• Lead Sponsor: Evangelisches Krankenhaus Lutherhaus gGmbH

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 Timeline

• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-14
• Study First Posted: 2012-01-19
• Study Start: 2012-02
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2017-11-28
• Results First Submitted QC: 2018-07-21
• Status Verified: 2019-01
• Results First Posted: 2019-01-17
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 436

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Alendronate	Alendronate	-

Primary Outcome Measures

Name	Time	Method
Number of New Osteoporotic Fractures	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 Outcome Measures

Name	Time	Method
Mortality	From baseline to study termination (mean duration 5.6 months)	Number of deaths
Combination of New Osteoporotic Fractures and Deaths	From baseline to study termination (mean duration 5.6 months)	Number of participants with a new osteoporotic fracture or death

Trial Locations

Locations (1)

Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele; 🇩🇪 Essen, Germany