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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

NCT01512446 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2019-02-12

Study results available
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Summary

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

Conditions

Interventions

DRUG

Alendronate

70 mg per week

DRUG

Placebo

1 pill per week

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Evangelisches Krankenhaus Lutherhaus gGmbH

    lead INDUSTRY

Principal Investigators

  • Johannes Pfeilschifter, Prof. Dr. med. · Alfried Krupp Krankenhaus Essen Steele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01512446 on ClinicalTrials.gov