Skip to main content
OpenTrials
Completed

NCT Number: NCT03472846

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Vienna; St. Vincent Hospital

Vienna, 1060, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolia, 60 Mg/mL Subcutaneous Solution

Drug

antiresorptive treatment with Prolia

Teriparatide

Drug

osteoanabolic treatment with Forsteo

Primary outcomes

  1. detection of microRNA concentration in serum

    Time frame: 24 months

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

Secondary outcomes

  1. microRNAs and changes in bone metabolism under treatment

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • St. Vincent Hospital, Vienna

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 21, 2018
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.