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

Phase 4

Suspended

• Conditions: Bone Marrow Oedema Syndrome; High Turnover Bone Disease; Quality of Life
• Interventions: Drug: Placebo Teriparatide; Drug: Placebo Denosumab; Drug: Denosumab; Drug: Teriparatide

• Registration Number: NCT01734824
• Lead Sponsor: Medical University of Vienna

Brief 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

Detailed Description

Patients are assigned to receive either denosumab 60mg sc (once) or placebo or daily teriparatide sc for three months or placebo.

MRI examinations at baseline and after three months will be performed. Serum bone turnover markers will be evaluated as well as QoL questionnaires.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-02
• Study First Submitted QC: 2012-11-23
• Study First Posted: 2012-11-28
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• MRI diagnosed bone marrow edema

Exclusion Criteria

• any prior antiresorptive or osteoanabolic treatment
• any prior therapy with strontium ranelate
• Hyper-/hypocalcemia
• malignancies
• pregnancy
• and contraindication against denosumab or teriparatide

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Teriparatide	Placebo Teriparatide	daily subcutaneous teriparatide placebo injection
Placebo Denosumab	Placebo Denosumab	one subcutaneous injection of denosumab placebo
Denosumab	Denosumab	one subcutaneous injection of denosumab
Teriparatide	Teriparatide	daily subcutaneous injection of teriparatide 20µg for three months

Primary Outcome Measures

Name	Time	Method
Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs	baseline - month 1 - month 3	MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score

Trial Locations

Locations (1)

Medical University Vienna - St. Vincent Hospital; 🇦🇹 Vienna, Austria