Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03472846
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
St. Vincent Hospital, Vienna
Information provided by (Responsible Party):
Dr. Christian Muschitz, Medical University of Vienna

Brief 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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Diabetes Type 2 Drug: Prolia, 60 Mg/mL Subcutaneous Solution Drug: Teriparatide Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MicroRNAs Levels in Women With Postmenopausal Osteoporosis Under Antiresorptive or Osteoanabolic Treatment
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. microRNAs and changes in bone metabolism under treatment [ Time Frame: 24 months ]
    correlation of microRNA with bone turnover markers, fracture risk, BMD



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472846


Contacts
Layout table for location contacts
Contact: Roland Kocijan, M.D. +431599886600 roland.kocijan@bhs.at
Contact: Zora Messner, M.D. +431599886145 zora.messner@bhs.at

Locations
Layout table for location information
Austria
Medical University Vienna; St. Vincent Hospital Recruiting
Vienna, Austria, 1060
Contact: Christian Muschitz, M.D.    +43159988 ext 2119    christian.muschitz@bhs.at   
Contact: Zora Messner, M.D.    +43159988 ext 6145    zora.messner@bhs.at   
Principal Investigator: Roland Kocijan, M.D.         
Sub-Investigator: Zora Messner, M.D.         
Sub-Investigator: Christian Muschitz, M.D.         
Sub-Investigator: Heinrich Resch, M.D.         
Sub-Investigator: Judith Haschka, M.D.         
Sponsors and Collaborators
Medical University of Vienna
St. Vincent Hospital, Vienna

Layout table for additonal information
Responsible Party: Dr. Christian Muschitz, OA Priv. Doz. Dr. Christian Muschitz, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03472846     History of Changes
Other Study ID Numbers: MIDETE
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Osteoporosis, Postmenopausal
Diabetes Mellitus, Type 2
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Endocrine System Diseases
Denosumab
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents