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

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Osteoporosis; Diabetes Type 2

Treatments: Drug: Prolia, 60 Mg/mL Subcutaneous Solution; Drug: Teriparatide

Study type: Interventional

Funder types: Other

Identifiers

NCT03472846

MIDETE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Female

Ages: 60 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 4 patient groups

Group 1 - DMAB

Active Comparator group

Description:

postmenopausal women without type 2 diabetes mellitus treated with denosumab

Treatment:

Drug: Prolia, 60 Mg/mL Subcutaneous Solution

Group 2 - TPTD

Active Comparator group

Description:

postmenopausal women with type 2 Diabetes mellitus treated with teriparatide

Treatment:

Drug: Teriparatide

Group 3 - DMAB

Active Comparator group

Description:

postmenopausal women with type 2 diabetes mellitus treated with denosumab

Treatment:

Drug: Prolia, 60 Mg/mL Subcutaneous Solution

Group 4 - TPTD

Active Comparator group

Description:

postmenopausal women without type 2 diabetes mellitus treated with teriparatid

Treatment:

Drug: Teriparatide