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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03472846

Enrollment

Registered

2018-03-21

Start date

2017-03-01

Completion date

2022-09-30

Last updated

2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 2, Postmenopausal Osteoporosis

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.

Interventions

DRUGProlia, 60 Mg/mL Subcutaneous Solution

antiresorptive treatment with Prolia

DRUGTeriparatide

osteoanabolic treatment with Forsteo

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

60 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
detection of microRNA concentration in serum	24 months	influence of antiresorptive or osteoanabolic Treatment on microRNA levels in postmenopausal women with osteoporosis

Secondary

Measure	Time frame	Description
microRNAs and changes in bone metabolism under treatment	24 months	correlation of microRNA with bone turnover markers, fracture risk, BMD

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026