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NCT03472846 Clinical Trial

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

Diabetes Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03472846
Other study ID # MIDETE
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 1, 2017
Est. completion date September 30, 2022

Study information
Verified date January 2023
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date September 30, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 60 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Prolia, 60 Mg/mL Subcutaneous Solution
antiresorptive treatment with Prolia
• Teriparatide
osteoanabolic treatment with Forsteo

Locations
Country Name City State
Austria Medical University Vienna; St. Vincent Hospital Vienna

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Vienna St. Vincent Hospital, Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary detection of microRNA concentration in serum influence of antiresorptive or osteoanabolic Treatment on microRNA levels in postmenopausal women with osteoporosis 24 months
Secondary microRNAs and changes in bone metabolism under treatment correlation of microRNA with bone turnover markers, fracture risk, BMD 24 months
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