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

Osteoporosis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01512446
• Other study ID #: 2011.1.42
• Secondary ID: 2011-000290-31
• Status: Terminated
• Phase: Phase 3
• Start date: February 2012
• Est. completion date: March 2013

Study information

• Verified date: January 2019
• Source: Evangelisches Krankenhaus Lutherhaus gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 436
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Alendronate
70 mg per week
• Placebo
1 pill per week

Locations

Country	Name	City	State
Germany	Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele	Essen

Sponsors (2)

Lead Sponsor	Collaborator
Evangelisches Krankenhaus Lutherhaus gGmbH	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to study termination (mean duration 5.6 months)
Secondary	Mortality	Number of deaths	From baseline to study termination (mean duration 5.6 months)
Secondary	Combination of New Osteoporotic Fractures and Deaths	Number of participants with a new osteoporotic fracture or death	From baseline to study termination (mean duration 5.6 months)