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

Phase 4

Completed

• Conditions: Diabetes Type 2; Postmenopausal Osteoporosis
• Interventions: Drug: Prolia, 60 Mg/mL Subcutaneous Solution; Drug: Teriparatide

• Registration Number: NCT03472846
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-21
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 3 - DMAB	Prolia, 60 Mg/mL Subcutaneous Solution	postmenopausal women with type 2 diabetes mellitus treated with denosumab
Group 1 - DMAB	Prolia, 60 Mg/mL Subcutaneous Solution	postmenopausal women without type 2 diabetes mellitus treated with denosumab
Group 4 - TPTD	Teriparatide	postmenopausal women without type 2 diabetes mellitus treated with teriparatid
Group 2 - TPTD	Teriparatide	postmenopausal women with type 2 Diabetes mellitus treated with teriparatide

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Medical University Vienna; St. Vincent Hospital; 🇦🇹 Vienna, Austria