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

Sponsor

Medical University of Vienna (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03472846

Collaborator

St. Vincent Hospital, Vienna (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2017

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

detection of microRNA concentration in serum [24 months]
influence of antiresorptive or osteoanabolic Treatment on microRNA levels in postmenopausal women with osteoporosis

Secondary Outcome Measures

microRNAs and changes in bone metabolism under treatment [24 months]
correlation of microRNA with bone turnover markers, fracture risk, BMD

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University Vienna; St. Vincent Hospital	Vienna		Austria	1060

Sponsors and Collaborators

Medical University of Vienna
St. Vincent Hospital, Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Christian Muschitz, OA Priv. Doz. Dr. Christian Muschitz, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT03472846

Other Study ID Numbers:

MIDETE

First Posted:

Mar 21, 2018

Last Update Posted:

Oct 5, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Osteoporosis

Osteoporosis, Postmenopausal

Diabetes Mellitus, Type 2

Teriparatide

Study Results

No Results Posted as of Oct 5, 2021