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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT03472846 (opens ClinicalTrials.gov in a new tab)Other idMIDETE
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Overview

Status
Completed
Phase
Phase 4
Enrollment
26 participants (actual)
Sponsor
Medical University of Vienna · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Austria

Start
1 Mar 2017
Primary completion
1 Sept 2022
Completion
30 Sept 2022
First posted
21 Mar 2018
Last update posted
26 Jan 2023
Conditions
Postmenopausal Osteoporosis · Diabetes Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020202120222023
  1. Ph 4

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

    NCT03472846

    1 Mar 2017 to 30 Sept 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Prolia, 60 Mg/mL Subcutaneous SolutionDrug
  • TeriparatideDrug

Arms4

  • Active comparator

    Group 1 - DMAB

    postmenopausal women without type 2 diabetes mellitus treated with denosumab

  • Active comparator

    Group 2 - TPTD

    postmenopausal women with type 2 Diabetes mellitus treated with teriparatide

  • Active comparator

    Group 3 - DMAB

    postmenopausal women with type 2 diabetes mellitus treated with denosumab

  • Active comparator

    Group 4 - TPTD

    postmenopausal women without type 2 diabetes mellitus treated with teriparatid

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. detection of microRNA concentration in serum

    Time frame · 24 months

    Registry description

    influence of antiresorptive or osteoanabolic Treatment on microRNA levels in postmenopausal women with osteoporosis

Secondary outcomes(1)

  1. microRNAs and changes in bone metabolism under treatment

    Time frame · 24 months

    Registry description

    correlation of microRNA with bone turnover markers, fracture risk, BMD

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 60 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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