Osteoporosis (DXA-T-Score <-2,0 at lumbar spine, total hip or femur neck OR previous low trauma vertebral fractures) at high fracture risk
Conditions
Interventions
Trade Name: Fosamax
Product Name: Alendronat
Pharmaceutical Form: Tablet
INN or Proposed INN: Alendronsäure
Other descriptive name: Alendronat
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Evangelisches Krankenhaus Lutherhaus gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Postmenopausal women or men > 60 years, DXA T-Score at lumbar spine, total hip or femur neck =65 years) yes F.1.3.1 Number of subjects for this age range 6000
Exclusion criteria
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 Unrealisability of the intake instructions Hypocalcemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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?;Secondary Objective: Adverse events, death;Primary end point(s): Osteoporotic fractures ;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse events, death;Timepoint(s) of evaluation of this end point: Currently | — |
Countries
Germany
Contacts
Public ContactOsteologisches Forschungszentrum Es
Evangelisches Krankenhaus Lutherhaus gGmbH
Outcome results
None listed