DRUG
Prolia, 60 Mg/mL Subcutaneous Solution
antiresorptive treatment with Prolia
MiDeTe - microRNA Levels Under Denosumab and Teriparatide Therapy in Postmenopausal Osteoporosis
Status
Completed
Phase
Phase 4
Enrollment
26
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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 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
Treatment arms and agents.
DRUG
Teriparatide
osteoanabolic treatment with Forsteo
Timeline
From registration to results.
First posted
Mar 21, 2018
Study start
Mar 1, 2017
Primary completion
Sep 1, 2022
Study completion
Sep 30, 2022
Results posted
Not reported
Registry updated
Jan 26, 2023
Outcomes
What the study measures.
Primary outcomes
detection of microRNA concentration in serum
Time frame · 24 months
influence of antiresorptive or osteoanabolic Treatment on microRNA levels in postmenopausal women with osteoporosis
Secondary outcomes
microRNAs and changes in bone metabolism under treatment
Time frame · 24 months
correlation of microRNA with bone turnover markers, fracture risk, BMD
Eligibility
Who can take part.
- Minimum age
- 60 Years
- Maximum age
- 80 Years
- Sex
- FEMALE
- 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
Study locations
1 registered sites.
Austria. Showing up to 24 locations stored in the fast local snapshot.
Medical University Vienna; St. Vincent Hospital
Vienna, Austria
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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