- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03472846
MiDeTe - microRNA Levels Under Denosumab and Teriparatide Therapy in Postmenopausal Osteoporosis
MicroRNAs Levels in Women With Postmenopausal Osteoporosis Under Antiresorptive or Osteoanabolic Treatment
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1060
- Medical University Vienna; St. Vincent Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Postmenopausal women
- Age 60-80 years
- T-score according to DXA: <-2.5
- indication for osteoporosis therapy according to international guidelines
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1 - DMAB
postmenopausal women without type 2 diabetes mellitus treated with denosumab
|
antiresorptive treatment with Prolia
|
Active Comparator: Group 2 - TPTD
postmenopausal women with type 2 Diabetes mellitus treated with teriparatide
|
osteoanabolic treatment with Forsteo
|
Active Comparator: Group 3 - DMAB
postmenopausal women with type 2 diabetes mellitus treated with denosumab
|
antiresorptive treatment with Prolia
|
Active Comparator: Group 4 - TPTD
postmenopausal women without type 2 diabetes mellitus treated with teriparatid
|
osteoanabolic treatment with Forsteo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
detection of microRNA concentration in serum
Time Frame: 24 months
|
influence of antiresorptive or osteoanabolic Treatment on microRNA levels in postmenopausal women with osteoporosis
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
microRNAs and changes in bone metabolism under treatment
Time Frame: 24 months
|
correlation of microRNA with bone turnover markers, fracture risk, BMD
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Diabetes Mellitus, Type 2
- Osteoporosis
- Osteoporosis, Postmenopausal
- Physiological Effects of Drugs
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Teriparatide
Other Study ID Numbers
- MIDETE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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