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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Christian Muschitz, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01734824
First received: June 2, 2012
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Bone Marrow Oedema Syndrome
High Turnover Bone Disease
Quality of Life
Drug: Denosumab
Drug: Teriparatide
Drug: Placebo Denosumab
Drug: Placebo Teriparatide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs [ Time Frame: baseline - month 1 - month 3 ] [ Designated as safety issue: Yes ]
    MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score


Estimated Enrollment: 90
Study Start Date: May 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Teriparatide
daily subcutaneous injection of teriparatide 20µg for three months
Drug: Teriparatide
daily subcutaneous injection of teriparatide
Other Name: PTH 1-34
Placebo Comparator: Placebo Teriparatide
daily subcutaneous teriparatide placebo injection
Drug: Placebo Teriparatide
daily subcutaneous placebo injection
Other Name: PTH 1-34
Active Comparator: Denosumab
one subcutaneous injection of denosumab
Drug: Denosumab
sc RANKL-inhibitor
Other Name: Prolia
Active Comparator: Placebo Denosumab
one subcutaneous injection of denosumab placebo
Drug: Placebo Denosumab
one subcutaneous injection denosumab placebo
Other Name: Prolia

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734824

Locations
Austria
Medical University Vienna - St. Vincent Hospital
Vienna, Austria, 1060
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Christian Muschitz, MD Medical University of Vienna
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Christian Muschitz, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01734824     History of Changes
Other Study ID Numbers: Vinforce-012, Bone marrow edema
Study First Received: June 2, 2012
Last Updated: August 27, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
bone marrow edema, denosumab, PTH 1-84

Additional relevant MeSH terms:
Bone Diseases
Edema
Musculoskeletal Diseases
Signs and Symptoms
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014