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

January 25, 2023 updated by: Dr. Christian Muschitz, Medical University of Vienna

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1060
        • Medical University Vienna; St. Vincent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Prolia, 60 Mg/mL Subcutaneous Solution
antiresorptive treatment with Prolia
Active Comparator: Group 2 - TPTD
postmenopausal women with type 2 Diabetes mellitus treated with teriparatide
Drug: Teriparatide
osteoanabolic treatment with Forsteo
Active Comparator: Group 3 - DMAB
postmenopausal women with type 2 diabetes mellitus treated with denosumab
Drug: Prolia, 60 Mg/mL Subcutaneous Solution
antiresorptive treatment with Prolia
Active Comparator: Group 4 - TPTD
postmenopausal women without type 2 diabetes mellitus treated with teriparatid
Drug: Teriparatide
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

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

St. Vincent Hospital, Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 21, 2018

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIDETE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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