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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)

This study is currently recruiting participants.
Verified March 2012 by Evangelisches Krankenhaus Lutherhaus gGmbH
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Evangelisches Krankenhaus Lutherhaus gGmbH
ClinicalTrials.gov Identifier:
NCT01512446
First received: January 11, 2012
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoporosis
 Drug: Alendronate
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Evangelisches Krankenhaus Lutherhaus gGmbH:

Primary Outcome Measures:
  • Incidence of new osteoporotic fractures [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Equivalence of deaths with and without continued bisphosphonate therapy [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Incidence of the combination of fractures and deaths [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 7000
Study Start Date: January 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alendronate Drug: Alendronate
70 mg per week
Other Name: Fosamax
Placebo Comparator: Placebo Drug: Placebo
1 pill per week

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?

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512446

Contacts
Contact: Johannes Pfeilschifter, Prof. Dr. med. +49 (0)201 805 ext 1847 johannes.pfeilschifter@krupp-krankenhaus.de
Contact: Inga Steinebach, MD +49 (0)201 805 ext 1979 steinebach@osteo-fz.de

Locations
Germany
Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele Recruiting
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

No publications provided

Responsible Party: Evangelisches Krankenhaus Lutherhaus gGmbH
ClinicalTrials.gov Identifier: NCT01512446     History of Changes
Other Study ID Numbers: 2011.1.42, 2011-000290-31
Study First Received: January 11, 2012
Last Updated: March 21, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Diphosphonates
 Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013