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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)

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ClinicalTrials.gov Identifier: NCT01512446
Recruitment Status : Terminated (low recruitment rate)
First Posted : January 19, 2012
Last Update Posted : July 12, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Alendronate Drug: Placebo Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2012
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Alendronate Drug: Alendronate
70 mg per week
Other Name: Fosamax
Placebo Comparator: Placebo Drug: Placebo
1 pill per week


Outcome Measures

Primary Outcome Measures :
  1. Incidence of new osteoporotic fractures [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Equivalence of deaths with and without continued bisphosphonate therapy [ Time Frame: 24 months ]
  2. Incidence of the combination of fractures and deaths [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512446


Locations
Germany
Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele
Essen, Germany, 45276
Sponsors and Collaborators
Evangelisches Krankenhaus Lutherhaus gGmbH
German Federal Ministry of Education and Research
Investigators
Study Director: Johannes Pfeilschifter, Prof. Dr. med. Alfried Krupp Krankenhaus Essen Steele
More Information

Responsible Party: Evangelisches Krankenhaus Lutherhaus gGmbH
ClinicalTrials.gov Identifier: NCT01512446     History of Changes
Other Study ID Numbers: 2011.1.42
2011-000290-31 ( EudraCT Number )
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017

Keywords provided by Evangelisches Krankenhaus Lutherhaus gGmbH:
Osteoporosis
Osteoporotic fractures
Bisphosphonate
Pretreatment with bisphosphonates

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs