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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Evangelisches Krankenhaus Lutherhaus gGmbH.
Recruitment status was:  Recruiting
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Evangelisches Krankenhaus Lutherhaus gGmbH Identifier:
First received: January 11, 2012
Last updated: March 21, 2012
Last verified: March 2012
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Evangelisches Krankenhaus Lutherhaus gGmbH:

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

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

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?

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01512446

Contact: Johannes Pfeilschifter, Prof. Dr. med. +49 (0)201 805 ext 1847
Contact: Inga Steinebach, MD +49 (0)201 805 ext 1979

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

Responsible Party: Evangelisches Krankenhaus Lutherhaus gGmbH Identifier: NCT01512446     History of Changes
Other Study ID Numbers: 2011.1.42
2011-000290-31 ( EudraCT Number )
Study First Received: January 11, 2012
Last Updated: March 21, 2012

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

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on June 23, 2017