Sequential Therapies After Osteoanabolic Treatment
ConditionOsteoporosis, Postmenopausal
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age50-85
Sponsor424 General Military Hospital
About this trial
12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
a bone disease other than postmenopausal osteoporosis
use of medications other than romosozumab or teriparatide affecting bone metabolism during the last 12 months before entering the study
creatinine clearance <60 mL/min/1.73 m2
liver failure
Trial population
Postmenopausal women treated with severe osteoporosis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Zoledronate
Drugintravenous infusion
Denosumab
Drugsubcutaneous injection
Teriparatide
Drugsubcutaneous injection
Romosozumab
Drugsubcutaneous injection
Abaloparatide Injection (80 mcg)
Drugdaily subcutaneous injection
Treatment groups
150 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Romo-Zol group1 intervention
Group B: Romo-Dmab group1 intervention
Group C: Romo-PTH group2 interventions
Group D: PTH-Zol group1 intervention
Group E: PTH-Dmab group1 intervention
Group F: TPTD-Romo group1 intervention
Trial outcomes
Primary outcomes
1
lumbar spine bone mineral density
bone mineral density changes at the lumbar spine at 12 months measured by dual-energy absorptiometry (DXA)
Time frame
baseline to 12 monthsSecondary outcomes
1
femoral neck bone mineral density
bone mineral density changes at the femoral neck at 12 months measured by dual-energy absorptiometry (DXA)
Time frame
baseline to 12 months2
total hip bone mineral density
bone mineral density changes at the total hip at 12 months measured by dual-energy absorptiometry (DXA)
Time frame
baseline to 12 months3
P1NP
bone turnover (formation) marker
Time frame
baseline, 3 months, 6 months, 12 months4
CTx
bone turnover (resorption) marker
Time frame
baseline, 3 months, 6 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
424 General Military Hospital
Lead sponsor
Laikο General Hospital, Athens
Collaborator
251 Hellenic Air Force & VA General Hospital
Collaborator
KAT Hospital of Athens
Collaborator
Campus Biomedico - Roma
Collaborator
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano
Collaborator
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
Collaborator
University of Siena
Collaborator
Source ClinicalTrials.gov