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)

Evangelisches Krankenhaus Lutherhaus gGmbH

Status and phase: Terminated; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Alendronate; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01512446

2011.1.42

2011-000290-31 (EudraCT Number)

Details and patient eligibility

About

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

Full 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?

Enrollment: 436 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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436 participants in 2 patient groups, including a placebo group

Alendronate

Active Comparator group

Treatment:

Drug: Alendronate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo