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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 (BILANZ)

Primary Purpose

Osteoporosis

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Alendronate
Placebo
Sponsored by
Evangelisches Krankenhaus Lutherhaus gGmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Osteoporotic fractures, Bisphosphonate, Pretreatment with bisphosphonates

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Alendronate

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality
Number of deaths
Combination of New Osteoporotic Fractures and Deaths
Number of participants with a new osteoporotic fracture or death

Full Information

First Posted
January 11, 2012
Last Updated
January 24, 2019
Sponsor
Evangelisches Krankenhaus Lutherhaus gGmbH
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01512446
Brief Title
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
Acronym
BILANZ
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
low recruitment rate
Study Start Date
February 2012 (Actual)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Evangelisches Krankenhaus Lutherhaus gGmbH
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, Osteoporotic fractures, Bisphosphonate, Pretreatment with bisphosphonates

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
436 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alendronate
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Alendronate
Other Intervention Name(s)
Fosamax
Intervention Description
70 mg per week
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 pill per week
Primary Outcome Measure Information:
Title
Number of New Osteoporotic Fractures
Description
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.
Time Frame
From baseline to study termination (mean duration 5.6 months)
Secondary Outcome Measure Information:
Title
Mortality
Description
Number of deaths
Time Frame
From baseline to study termination (mean duration 5.6 months)
Title
Combination of New Osteoporotic Fractures and Deaths
Description
Number of participants with a new osteoporotic fracture or death
Time Frame
From baseline to study termination (mean duration 5.6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Pfeilschifter, Prof. Dr. med.
Organizational Affiliation
Alfried Krupp Krankenhaus Essen Steele
Official's Role
Study Director
Facility Information:
Facility Name
Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele
City
Essen
ZIP/Postal Code
45276
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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