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

Medical University of Vienna

Status and phase: Suspended; Phase 4

Conditions: Bone Marrow Oedema Syndrome; Quality of Life; High Turnover Bone Disease

Treatments: Drug: Placebo Teriparatide; Drug: Denosumab; Drug: Placebo Denosumab; Drug: Teriparatide

Study type: Interventional

Funder types: Other

Identifiers

NCT01734824

Bone marrow edema (Other Identifier)

Vinforce-012

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 4 patient groups, including a placebo group

Teriparatide

Active Comparator group

Description:

daily subcutaneous injection of teriparatide 20µg for three months

Treatment:

Drug: Teriparatide

Placebo Teriparatide

Placebo Comparator group

Description:

daily subcutaneous teriparatide placebo injection

Treatment:

Drug: Placebo Teriparatide

Denosumab

Active Comparator group

Description:

one subcutaneous injection of denosumab

Treatment:

Drug: Denosumab

Placebo Denosumab

Active Comparator group

Description:

one subcutaneous injection of denosumab placebo

Treatment:

Drug: Placebo Denosumab