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

Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bone Marrow Oedema Syndrome; High Turnover Bone Disease; Quality of Life

Intervention: Denosumab (Drug); Teriparatide (Drug); Placebo Denosumab (Drug); Placebo Teriparatide (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Christian Muschitz, MD, Principal Investigator, Affiliation: Medical University of Vienna

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

Clinical Details

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

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

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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 and Contacts

Medical University Vienna - St. Vincent Hospital, Vienna 1060, Austria
Additional Information

non-profit web page

Starting date: May 2012
Last updated: August 27, 2013

Page last updated: August 23, 2015

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