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

Medical University of Vienna90 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Bone Marrow Oedema Syndrome High Turnover Bone Disease Quality of Life

Interventions

DenosumabDRUG

sc RANKL-inhibitor

TeriparatideDRUG

daily subcutaneous injection of teriparatide

Placebo DenosumabDRUG

one subcutaneous injection denosumab placebo

Placebo Teriparatide

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University Vienna - St. Vincent Hospital

Vienna, Vienna, Austria

Outcomes

Primary Outcomes

Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs

MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score

Time frame: baseline - month 1 - month 3

Data from ClinicalTrials.gov

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