NCT03472846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

5.5 years

First QC Date

March 14, 2018

Last Update Submit

January 25, 2023

Conditions

Postmenopausal OsteoporosisDiabetes Type 2

Outcome Measures

Primary Outcomes (1)

  • detection of microRNA concentration in serum

    influence of antiresorptive or osteoanabolic Treatment on microRNA levels in postmenopausal women with osteoporosis

    24 months

Secondary Outcomes (1)

  • microRNAs and changes in bone metabolism under treatment

    24 months

Study Arms (4)

Group 1 - DMAB

ACTIVE COMPARATOR

postmenopausal women without type 2 diabetes mellitus treated with denosumab

Drug: Prolia, 60 Mg/mL Subcutaneous Solution

Group 2 - TPTD

ACTIVE COMPARATOR

postmenopausal women with type 2 Diabetes mellitus treated with teriparatide

Drug: Teriparatide

Group 3 - DMAB

ACTIVE COMPARATOR

postmenopausal women with type 2 diabetes mellitus treated with denosumab

Drug: Prolia, 60 Mg/mL Subcutaneous Solution

Group 4 - TPTD

ACTIVE COMPARATOR

postmenopausal women without type 2 diabetes mellitus treated with teriparatid

Drug: Teriparatide

Interventions

Prolia, 60 Mg/mL Subcutaneous SolutionDRUG

antiresorptive treatment with Prolia

Group 1 - DMABGroup 3 - DMAB
TeriparatideDRUG

osteoanabolic treatment with Forsteo

Group 2 - TPTDGroup 4 - TPTD

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women
  • Age 60-80 years
  • T-score according to DXA: \<-2.5
  • indication for osteoporosis therapy according to international guidelines

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna; St. Vincent Hospital

Vienna, 1060, Austria

Location

MeSH Terms

Conditions

Osteoporosis, PostmenopausalDiabetes Mellitus, Type 2

Interventions

DenosumabTeriparatide

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsParathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptides

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
OA Priv. Doz. Dr. Christian Muschitz

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 21, 2018

Study Start

March 1, 2017

Primary Completion

September 1, 2022

Study Completion

September 30, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

AU(1)