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

Primary Purpose

Bone Marrow Oedema Syndrome, High Turnover Bone Disease, Quality of Life

Status
Suspended
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Denosumab
Teriparatide
Placebo Denosumab
Placebo Teriparatide
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Marrow Oedema Syndrome focused on measuring bone marrow edema, denosumab, PTH 1-84

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University Vienna - St. Vincent Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Teriparatide

Placebo Teriparatide

Denosumab

Placebo Denosumab

Arm Description

daily subcutaneous injection of teriparatide 20µg for three months

daily subcutaneous teriparatide placebo injection

one subcutaneous injection of denosumab

one subcutaneous injection of denosumab placebo

Outcomes

Primary Outcome Measures

Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs
MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score

Secondary Outcome Measures

Full Information

First Posted
June 2, 2012
Last Updated
September 22, 2015
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01734824
Brief Title
Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo
Official Title
Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Suspended
Why Stopped
no patients randomized
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Marrow Oedema Syndrome, High Turnover Bone Disease, Quality of Life
Keywords
bone marrow edema, denosumab, PTH 1-84

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Teriparatide
Arm Type
Active Comparator
Arm Description
daily subcutaneous injection of teriparatide 20µg for three months
Arm Title
Placebo Teriparatide
Arm Type
Placebo Comparator
Arm Description
daily subcutaneous teriparatide placebo injection
Arm Title
Denosumab
Arm Type
Active Comparator
Arm Description
one subcutaneous injection of denosumab
Arm Title
Placebo Denosumab
Arm Type
Active Comparator
Arm Description
one subcutaneous injection of denosumab placebo
Intervention Type
Drug
Intervention Name(s)
Denosumab
Other Intervention Name(s)
Prolia
Intervention Description
sc RANKL-inhibitor
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
PTH 1-34
Intervention Description
daily subcutaneous injection of teriparatide
Intervention Type
Drug
Intervention Name(s)
Placebo Denosumab
Other Intervention Name(s)
Prolia
Intervention Description
one subcutaneous injection denosumab placebo
Intervention Type
Drug
Intervention Name(s)
Placebo Teriparatide
Other Intervention Name(s)
PTH 1-34
Intervention Description
daily subcutaneous placebo injection
Primary Outcome Measure Information:
Title
Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs
Description
MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score
Time Frame
baseline - month 1 - month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Muschitz, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Vienna - St. Vincent Hospital
City
Vienna
ZIP/Postal Code
1060
Country
Austria

12. IPD Sharing Statement

Links:
URL
http://www.vinforce.at
Description
non-profit web page

Learn more about this trial

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

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