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

Primary Purpose

Postmenopausal Osteoporosis, Diabetes Type 2

Status

Completed

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

Prolia, 60 Mg/mL Subcutaneous Solution

Teriparatide

About this trial

This is an interventional diagnostic trial for Postmenopausal Osteoporosis

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Medical University Vienna; St. Vincent Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Group 1 - DMAB

Group 2 - TPTD

Group 3 - DMAB

Group 4 - TPTD

Arm Description

postmenopausal women without type 2 diabetes mellitus treated with denosumab

postmenopausal women with type 2 Diabetes mellitus treated with teriparatide

postmenopausal women with type 2 diabetes mellitus treated with denosumab

postmenopausal women without type 2 diabetes mellitus treated with teriparatid

Outcomes

Primary Outcome Measures

detection of microRNA concentration in serum

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

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

Full Information

NCT ID

NCT03472846

First Posted

March 14, 2018

Last Updated

January 25, 2023

Sponsor

Medical University of Vienna

Collaborators

St. Vincent Hospital, Vienna

1. Study Identification

Unique Protocol Identification Number

NCT03472846

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

September 1, 2022 (Actual)

Study Completion Date

September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

Collaborators

St. Vincent Hospital, Vienna

4. Oversight

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.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postmenopausal Osteoporosis, Diabetes Type 2

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1 - DMAB

Arm Type

Active Comparator

Arm Description

postmenopausal women without type 2 diabetes mellitus treated with denosumab

Arm Title

Group 2 - TPTD

Arm Type

Active Comparator

Arm Description

postmenopausal women with type 2 Diabetes mellitus treated with teriparatide

Arm Title

Group 3 - DMAB

Arm Type

Active Comparator

Arm Description

postmenopausal women with type 2 diabetes mellitus treated with denosumab

Arm Title

Group 4 - TPTD

Arm Type

Active Comparator

Arm Description

postmenopausal women without type 2 diabetes mellitus treated with teriparatid

Intervention Type

Drug

Intervention Name(s)

Prolia, 60 Mg/mL Subcutaneous Solution

Intervention Description

antiresorptive treatment with Prolia

Intervention Type

Drug

Intervention Name(s)

Teriparatide

Intervention Description

osteoanabolic treatment with Forsteo

Primary Outcome Measure Information:

Title

detection of microRNA concentration in serum

Description

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

Time Frame

24 months

Secondary Outcome Measure Information:

Title

microRNAs and changes in bone metabolism under treatment

Description

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

Time Frame

24 months

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Medical University Vienna; St. Vincent Hospital

City

Vienna

ZIP/Postal Code

1060

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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