Bone Marrow Oedema SyndromePhase 4NCT01734824
Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo
A Phase 4 study testing Denosumab and Teriparatide in people with Bone Marrow Oedema Syndrome and High Turnover Bone Disease, run by Medical University of Vienna at 1 site in Austria.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bone Marrow Oedema Syndrome, High Turnover Bone Disease, Quality of Life
- What is being tested?
- Denosumab and Teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteAustria
- Study dates
- May 2012to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MRI diagnosed bone marrow edema
Who cannot join
- any prior antiresorptive or osteoanabolic treatment
- any prior therapy with strontium ranelate
- Hyper-/hypocalcemia
- malignancies
- pregnancy
- and contraindication against denosumab or teriparatide
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Vienna - St. Vincent Hospital
Vienna, State of Vienna, 1060
About this study
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
Read the 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.
- Being tested
- Denosumab, Teriparatide, Placebo Denosumab, Placebo Teriparatide
- Keywords
- bone marrow edema, denosumab, PTH 1-84
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Also called Prolia
sc RANKL-inhibitor
TeriparatideDrug
Also called PTH 1-34
daily subcutaneous injection of teriparatide
Placebo DenosumabDrug
Also called Prolia
one subcutaneous injection denosumab placebo
Placebo TeriparatideDrug
Also called PTH 1-34
daily subcutaneous placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide | Active comparator | daily subcutaneous injection of teriparatide 20µg for three months Receives: Drug: Teriparatide |
| Placebo Teriparatide | Placebo comparator | daily subcutaneous teriparatide placebo injection Receives: Drug: Placebo Teriparatide |
| Denosumab | Active comparator | one subcutaneous injection of denosumab Receives: Drug: Denosumab |
| Placebo Denosumab | Active comparator | one subcutaneous injection of denosumab placebo Receives: Drug: Placebo Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs
MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score
Measured: baseline - month 1 - month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Why it stopped: no patients randomized
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow Oedema SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christian Muschitz, Medical University of Vienna
- Investigators
- Christian Muschitz, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734824
- Sponsor's protocol ID
- Vinforce-012
- Other IDs
- Bone marrow edema
- Status last verified
- Sep 2015
- First submitted
- 2 Jun 2012
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo
- ClinicalTrials.gov ID
- NCT01734824
- Acronym / sponsor ID
- Vinforce-012
- Keywords
- bone marrow edema, denosumab, PTH 1-84
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: no patients randomized
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Teriparatide | Active comparator | Drug: Teriparatidedaily subcutaneous injection of teriparatide 20µg for three months |
| Placebo Teriparatide | Placebo comparator | Drug: Placebo Teriparatidedaily subcutaneous teriparatide placebo injection |
| Denosumab | Active comparator | Drug: Denosumabone subcutaneous injection of denosumab |
| Placebo Denosumab | Active comparator | Drug: Placebo Denosumabone subcutaneous injection of denosumab placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- MRI diagnosed bone marrow edema
Key exclusion criteria (6 listed)
- any prior antiresorptive or osteoanabolic treatment
- any prior therapy with strontium ranelate
- Hyper-/hypocalcemia
- malignancies
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DenosumabAlso: Proliasc RANKL-inhibitor | Drug | Denosumab |
| TeriparatideAlso: PTH 1-34daily subcutaneous injection of teriparatide | Drug | Teriparatide |
| Placebo DenosumabAlso: Proliaone subcutaneous injection denosumab placebo | Drug | Placebo Denosumab |
| Placebo TeriparatideAlso: PTH 1-34daily subcutaneous placebo injection | Drug | Placebo Teriparatide |
Primary outcome
Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs
Time frame: baseline - month 1 - month 3
MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Muschitz, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosumab and Teriparatide in people with Bone Marrow Oedema Syndrome and High Turnover Bone Disease, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs (time frame: baseline - month 1 - month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.