Postmenopausal OsteoporosisPhase 4NCT03472846
MiDeTe - microRNA Levels Under Denosumab and Teriparatide Therapy in Postmenopausal Osteoporosis
A Phase 4 study testing Prolia, 60 Mg/mL Subcutaneous Solution and Teriparatide in people with Postmenopausal Osteoporosis and Diabetes Type 2, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this study is the quantitative determination of bone-specific microRNAs in the serum of postmenopausal women with osteoporosis during antiresorptive or osteoanabolic therapy. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis, Diabetes Type 2
- What is being tested?
- Prolia, 60 Mg/mL Subcutaneous Solution and Teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2017to 30 Sep 2022
- 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- Age 60-80 years
- T-score according to DXA: <-2.5
- indication for osteoporosis therapy according to international guidelines
Who cannot join
- Diabetes mellitus type 1
- renal insufficiency III-V °
- Cirrhosis hepatis (Child B or higher)
- Chronic alcohol abuse
- rheumatic disease (RA, SpA, SLE)
- Malignancies (<5 years)
- Eating Disorder (anorexia nervosa, bulimia)
- bone-specific pretreatment (DMAB, TPTD, strontium ranelate, SERMs) Bisphosphonate treatment is allowed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MicroRNAs Levels in Women With Postmenopausal Osteoporosis Under Antiresorptive or Osteoanabolic Treatment
The aim of this study is the quantitative determination of bone-specific microRNAs in the serum of postmenopausal women with osteoporosis during antiresorptive or osteoanabolic therapy.
Read the detailed description
Primarily the influence of the therapeutic treatment on the microRNA concentration in the serum (treatment-response) and the relation between microRNA serum levels and changes of the bone mineral density will be investigated.
These data will help to examine the use of microRNAs as novel diagnostic biomarkers for the diagnosis of osteoporosis and targeted therapeutic treatment of patients.
- Conditions
- Postmenopausal Osteoporosis, Diabetes Type 2
- Being tested
- Prolia, 60 Mg/mL Subcutaneous Solution, Teriparatide
- Medical subject headings
- Osteoporosis, Postmenopausal, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolia, 60 Mg/mL Subcutaneous SolutionDrug
antiresorptive treatment with Prolia
TeriparatideDrug
osteoanabolic treatment with Forsteo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - DMAB | Active comparator | postmenopausal women without type 2 diabetes mellitus treated with denosumab Receives: Drug: Prolia, 60 Mg/mL Subcutaneous Solution |
| Group 2 - TPTD | Active comparator | postmenopausal women with type 2 Diabetes mellitus treated with teriparatide Receives: Drug: Teriparatide |
| Group 3 - DMAB | Active comparator | postmenopausal women with type 2 diabetes mellitus treated with denosumab Receives: Drug: Prolia, 60 Mg/mL Subcutaneous Solution |
| Group 4 - TPTD | Active comparator | postmenopausal women without type 2 diabetes mellitus treated with teriparatid Receives: Drug: Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of microRNA concentration in serum
influence of antiresorptive or osteoanabolic Treatment on microRNA levels in postmenopausal women with osteoporosis
Measured: 24 months
Secondary outcomes (1)
microRNAs and changes in bone metabolism under treatment
correlation of microRNA with bone turnover markers, fracture risk, BMD
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start1 Mar 2017
- Primary completion1 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- St. Vincent Hospital, Vienna
- Responsible party
- Principal investigator, Dr. Christian Muschitz, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472846
- Sponsor's protocol ID
- MIDETE
- Status last verified
- Jan 2023
- First submitted
- 14 Mar 2018
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNAs Levels in Women With Postmenopausal Osteoporosis Under Antiresorptive or Osteoanabolic Treatment
- ClinicalTrials.gov ID
- NCT03472846
- Acronym / sponsor ID
- MIDETE
- Conditions
- Postmenopausal Osteoporosis, Diabetes Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- St. Vincent Hospital, Vienna
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 21 Mar 2018 (actual)
- 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 aim of this study is the quantitative determination of bone-specific microRNAs in the serum of postmenopausal women with osteoporosis during antiresorptive or osteoanabolic therapy.
Detailed description
Primarily the influence of the therapeutic treatment on the microRNA concentration in the serum (treatment-response) and the relation between microRNA serum levels and changes of the bone mineral density will be investigated.
These data will help to examine the use of microRNAs as novel diagnostic biomarkers for the diagnosis of osteoporosis and targeted therapeutic treatment of patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - DMAB | Active comparator | Drug: Prolia, 60 Mg/mL Subcutaneous Solutionpostmenopausal women without type 2 diabetes mellitus treated with denosumab |
| Group 2 - TPTD | Active comparator | Drug: Teriparatidepostmenopausal women with type 2 Diabetes mellitus treated with teriparatide |
| Group 3 - DMAB | Active comparator | Drug: Prolia, 60 Mg/mL Subcutaneous Solutionpostmenopausal women with type 2 diabetes mellitus treated with denosumab |
| Group 4 - TPTD | Active comparator | Drug: Teriparatidepostmenopausal women without type 2 diabetes mellitus treated with teriparatid |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women
- Age 60-80 years
- T-score according to DXA: <-2.5
- indication for osteoporosis therapy according to international guidelines
Key exclusion criteria (8 listed)
- Diabetes mellitus type 1
- renal insufficiency III-V °
- Cirrhosis hepatis (Child B or higher)
- Chronic alcohol abuse
- rheumatic disease (RA, SpA, SLE)
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 |
|---|---|---|
| Prolia, 60 Mg/mL Subcutaneous Solutionantiresorptive treatment with Prolia | Drug | Group 1 - DMAB, Group 3 - DMAB |
| Teriparatideosteoanabolic treatment with Forsteo | Drug | Group 2 - TPTD, Group 4 - TPTD |
Primary outcome
detection of microRNA concentration in serum
Time frame: 24 months
influence of antiresorptive or osteoanabolic Treatment on microRNA levels in postmenopausal women with osteoporosis
1 secondary outcome
microRNAs and changes in bone metabolism under treatment
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Postmenopausal Osteoporosis
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prolia, 60 Mg/mL Subcutaneous Solution and Teriparatide in people with Postmenopausal Osteoporosis and Diabetes Type 2, 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 26 Jan 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
detection of microRNA concentration in serum (time frame: 24 months). 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 26 Jan 2023.