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
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