Comparison of the effect of an ongoing treatment with alendronate or a drug holidayon the fracture risk in osteoporotic patients with a bisphosphonate long term therapy

Phase 3

• Conditions: M81; M80; Osteoporosis without pathological fracture; Osteoporosis with pathological fracture

• Registration Number: DRKS00000721
• Lead Sponsor: Evangelisches Krankenhaus Lutherhaus gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-22
• Study Completion: 2013-03-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 424

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

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Osteoporotic fractures within 24 months, detected via patient interview and medical reporting

Secondary Outcome Measures

Name	Time	Method
<br>Adverse events, death