interventional
N/A
1 country
2
To demonstrate the reduction in the progression of erosion volume in the denosumab group vs zoledronic acid group
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 13, 2026
Actual (reported)The primary endpoint is the difference in mean change of total erosion volume (mm3) of target joints (II, III, IV, V distal and proximal interphalangeal joints and II, III, IV, V metacarpal phalangeal joints) assessed with high resolution peripheral quantitative computed tomography (HRpQCT) using standardized approach between baseline (V1) and 12 months after baseline (V4)
The secondary endpoint will be the number and proportion of interphalangeal joints progressing from non‑erosive disease, defined as S/J phase at baseline, to erosive disease, defined as E phase at 48 weeks.
The change from baseline to Month 12 in patient‑reported and functional outcomes, including AUSCAN (AUStralian CANadian Osteoarthritis Hand Index), FIHOA (Functional Index of Hand Osteoarthritis), and Pain VAS, reflecting pain, hand function, and disability from the patient perspective.
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Formulated product
Obodence 60 mg solution for injection in pre-filled syringe
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Obodence 60 mg solution for injection in pre-filled syringe
Named ingredient: Denosumab
View registry recordAzienda Ospedaliera Universitaria Integrata Verona
Verona, 37126, Italy
Azienda Ospedaliera di Padova
Padova, 35128, Italy
Giovanni Adami
First Submitted
May 13, 2026
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
A Study to Evaluate Denosumab in Young Patients With Primary Breast Cancer
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