MiDeTe - microRNA Levels Under Denosumab and Teriparatide Therapy in Postmenopausal Osteoporosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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MicroRNAs Levels in Women With Postmenopausal Osteoporosis Under Antiresorptive or Osteoanabolic Treatment

Conditions
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Postmenopausal Osteoporosis, Diabetes Type 2

Intervention / Treatment
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* Drug: Prolia, 60 Mg/mL Subcutaneous Solution
* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 - DMAB<br>postmenopausal women without type 2 diabetes mellitus treated with denosumab | Drug: Prolia, 60 Mg/mL Subcutaneous Solution<br>* antiresorptive treatment with Prolia<br>|
| Active Comparator: Group 2 - TPTD<br>postmenopausal women with type 2 Diabetes mellitus treated with teriparatide | Drug: Teriparatide<br>* osteoanabolic treatment with Forsteo<br>|
| Active Comparator: Group 3 - DMAB<br>postmenopausal women with type 2 diabetes mellitus treated with denosumab | Drug: Prolia, 60 Mg/mL Subcutaneous Solution<br>* antiresorptive treatment with Prolia<br>|
| Active Comparator: Group 4 - TPTD<br>postmenopausal women without type 2 diabetes mellitus treated with teriparatid | Drug: Teriparatide<br>* osteoanabolic treatment with Forsteo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of microRNA concentration in serum | 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 | correlation of microRNA with bone turnover markers, fracture risk, BMD | 24 months |