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 (BILANZ)

January 24, 2019 updated by: Prof. Dr. med. Johannes Pfeilschifter, Evangelisches Krankenhaus Lutherhaus gGmbH
The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

436

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany, 45276
        • Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
1 pill per week
Active Comparator: Alendronate
Drug: Alendronate
70 mg per week
Other Names:
  • Fosamax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to study termination (mean duration 5.6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: From baseline to study termination (mean duration 5.6 months)
Number of deaths
From baseline to study termination (mean duration 5.6 months)
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
From baseline to study termination (mean duration 5.6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evangelisches Krankenhaus Lutherhaus gGmbH

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Study Director: Johannes Pfeilschifter, Prof. Dr. med., Alfried Krupp Krankenhaus Essen Steele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 14, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011.1.42
  • 2011-000290-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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