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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-09-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Bone Marrow Oedema Syndrome High Turnover Bone Disease Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Teriparatide

daily subcutaneous injection of teriparatide 20µg for three months

Group Type ACTIVE_COMPARATOR

Teriparatide

Intervention Type DRUG

daily subcutaneous injection of teriparatide

Placebo Teriparatide

daily subcutaneous teriparatide placebo injection

Group Type PLACEBO_COMPARATOR

Placebo Teriparatide

Intervention Type DRUG

daily subcutaneous placebo injection

Denosumab

one subcutaneous injection of denosumab

Group Type ACTIVE_COMPARATOR

Denosumab

Intervention Type DRUG

sc RANKL-inhibitor

Placebo Denosumab

one subcutaneous injection of denosumab placebo

Group Type ACTIVE_COMPARATOR

Placebo Denosumab

Intervention Type DRUG

one subcutaneous injection denosumab placebo

Interventions

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Denosumab

sc RANKL-inhibitor

Intervention Type DRUG

Teriparatide

daily subcutaneous injection of teriparatide

Intervention Type DRUG

Placebo Denosumab

one subcutaneous injection denosumab placebo

Intervention Type DRUG

Placebo Teriparatide

daily subcutaneous placebo injection

Intervention Type DRUG

Other Intervention Names

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Prolia PTH 1-34 Prolia PTH 1-34

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No