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Osteoporosis | 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 research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Osteoporosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Alendronate70 mg per week

Drug:Placebo1 pill per week

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Alendronate

Placebo

Study Status

Terminated

Start Date: February 2012

Completed Date: March 2013

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Number of New Osteoporotic Fractures

Secondary Outcome: Mortality

Study sponsors, principal investigator, and references

Principal Investigator: Johannes Pfeilschifter, Prof. Dr. med.

Lead Sponsor: Evangelisches Krankenhaus Lutherhaus gGmbH

Collaborator: German Federal Ministry of Education and Research

More information:https://clinicaltrials.gov/show/NCT01512446

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