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CompletedNCT03472846Updated Jan 26, 2023

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

A Phase 4 interventional study of Prolia, 60 Mg/mL Subcutaneous Solution and Teriparatide in Postmenopausal Osteoporosis and Diabetes Type 2, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to female participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-26.

Sponsored by Medical University of Vienna · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
60 Years to 80 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Postmenopausal Osteoporosis
  • Diabetes Type 2
03

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Active comparator
    Group 1 - DMAB

    postmenopausal women without type 2 diabetes mellitus treated with denosumab

    Drug: Prolia, 60 Mg/mL Subcutaneous Solution

  • Active comparator
    Group 2 - TPTD

    postmenopausal women with type 2 Diabetes mellitus treated with teriparatide

    Drug: Teriparatide

  • Active comparator
    Group 3 - DMAB

    postmenopausal women with type 2 diabetes mellitus treated with denosumab

    Drug: Prolia, 60 Mg/mL Subcutaneous Solution

  • Active comparator
    Group 4 - TPTD

    postmenopausal women without type 2 diabetes mellitus treated with teriparatid

    Drug: Teriparatide

Interventions

  • DrugProlia, 60 Mg/mL Subcutaneous Solution

    antiresorptive treatment with Prolia

  • DrugTeriparatide

    osteoanabolic treatment with Forsteo

05

What researchers measure

Primary outcomes

  1. detection of microRNA concentration in serum

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

    Time frame: 24 months

Secondary outcomes

  1. microRNAs and changes in bone metabolism under treatment

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

    Time frame: 24 months

06

Study locations

1 site
  • Medical University Vienna; St. Vincent Hospital
    Vienna, 1060, Austria
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03472846
Lead sponsor
Medical University of Vienna
Collaborators
St. Vincent Hospital, Vienna
Responsible party
Dr. Christian Muschitz (OA Priv. Doz. Dr. Christian Muschitz, Medical University of Vienna) — Principal investigator
First posted
Mar 21, 2018
Start date
Mar 1, 2017
Primary completion
Sep 1, 2022
Completion
Sep 30, 2022
Last update
Jan 26, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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