Study to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis

Conditions: Osteoporosis (DXA-T-Score <-2,0 at lumbar spine, total hip or femur neck OR previous low trauma vertebral fractures) at high fracture risk
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-000290-31-DE

Lead Sponsor: Evangelisches Krankenhaus Lutherhaus gGmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Postmenopausal women or men > 60 years,
DXA T-Score at lumbar spine, total hip or femur neck <-2,0 OR at least one low traumatic vertebral fracture grade 2/3 or multiple low traumatic vertebral fractures regardless of bone density 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6000

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures