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NCT01734824 Clinical Trial

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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT01734824
Other study ID # Vinforce-012
Secondary ID Bone marrow edem
Status Suspended
Phase Phase 4
First received June 2, 2012
Last updated September 22, 2015
Start date May 2012
Est. completion date September 2015

Study information
Verified date September 2015
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Suspended
Enrollment 90
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Denosumab
sc RANKL-inhibitor
• Teriparatide
daily subcutaneous injection of teriparatide
• Placebo Denosumab
one subcutaneous injection denosumab placebo
• Placebo Teriparatide
daily subcutaneous placebo injection

Locations
Country Name City State
Austria Medical University Vienna - St. Vincent Hospital Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score baseline - month 1 - month 3 Yes
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