MiDeTe

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postmenopausal Osteoporosis Diabetes Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group 1 - DMAB

postmenopausal women without type 2 diabetes mellitus treated with denosumab

Group Type ACTIVE_COMPARATOR

Prolia, 60 Mg/mL Subcutaneous Solution

Intervention Type DRUG

antiresorptive treatment with Prolia

Group 2 - TPTD

postmenopausal women with type 2 Diabetes mellitus treated with teriparatide

Group Type ACTIVE_COMPARATOR

Teriparatide

Intervention Type DRUG

osteoanabolic treatment with Forsteo

Group 3 - DMAB

postmenopausal women with type 2 diabetes mellitus treated with denosumab

Group Type ACTIVE_COMPARATOR

Prolia, 60 Mg/mL Subcutaneous Solution

Intervention Type DRUG

antiresorptive treatment with Prolia

Group 4 - TPTD

postmenopausal women without type 2 diabetes mellitus treated with teriparatid

Group Type ACTIVE_COMPARATOR

Teriparatide

Intervention Type DRUG

osteoanabolic treatment with Forsteo

Interventions

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Prolia, 60 Mg/mL Subcutaneous Solution

antiresorptive treatment with Prolia

Intervention Type DRUG

Teriparatide

osteoanabolic treatment with Forsteo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes