Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo

NCT01734824 · Status: SUSPENDED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2015-09-23

No results posted yet for this study

Summary

The etiology of bone marrow edema (BME) is still uncertain. Several studies report therapeutic success with antiresorptive drugs.

This study investigates antiresorptive and osteoanabolic drugs versus placebo in BME

Conditions

  • Bone Marrow Oedema Syndrome
  • High Turnover Bone Disease
  • Quality of Life

Interventions

DRUG

Denosumab

sc RANKL-inhibitor

DRUG

Teriparatide

daily subcutaneous injection of teriparatide

DRUG

Placebo Denosumab

one subcutaneous injection denosumab placebo

DRUG

Placebo Teriparatide

daily subcutaneous placebo injection

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Christian Muschitz, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Austria

Study Locations

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Entities

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 NCT01734824 on ClinicalTrials.gov