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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01512446
• Date of registration: 11/01/2012
• Primary sponsor: Evangelisches Krankenhaus Lutherhaus gGmbH
• Public 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 BILANZ
• Date of first enrolment: January 2012
• Target sample size: 7000
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01512446
• 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

Countries of recruitment

Germany

Contacts

• Name: Johannes Pfeilschifter, Prof. Dr. med.

• Name: Johannes Pfeilschifter, Prof. Dr. med.
• Affiliation: Alfried Krupp Krankenhaus Essen Steele

Key inclusion & exclusion 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



Age minimum: 60 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoporosis

Intervention(s)

Drug: Alendronate

Drug: Placebo

Primary Outcome(s)

Incidence of new osteoporotic fractures [Time Frame: 24 months]

Secondary Outcome(s)

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]

Secondary ID(s)

2011-000290-31

2011.1.42

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

German Federal Ministry of Education and Research