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SAFEST: Zoledronic Acid Post-Denosumab Discontinuation in Postmenopausal Osteoporosis
NCT06767150Phase 4
Key facts
- Status
- Recruiting
- Start
- Oct 2025
- Primary completion
- Oct 2030
- Countries
- 1
- Sponsor
- Centre hospitalier universitaire de Toulouse
- Modality
- Small Molecules
- Drugs
- zoledronic acid
- Conditions
- postmenopausal osteoporosis
01
Overview
Phase 4, randomised, open-label trial of zoledronic acid in postmenopausal osteoporosis (2 arms), sponsored by Centre hospitalier universitaire de Toulouse. Primary endpoint: Maintain lumbar bone mineral density (BMD) at 1 year. Started Oct 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Intensive biomarkers-guided arm
First infusion of ZOL 5 mg at study start, second infusion when crosslaps levels reach 300 pg/mL, no later than month-12.
Standard treatment arm
First infusion of ZOL 5 mg at study start, potentially a rescue second infusion at month-12 in case of unfavorable outcome.
03
Who it enrols
Postmenopausal women with osteoporosis treated with denosumab for at least 2 years who are withdrawing from denosumab after achieving therapeutic targets, with a history of severe fracture or T-score <= -2.5 prior to denosumab.
04
Endpoints
Primary
Maintain lumbar bone mineral density (BMD)
Secondary
Maintain hip bone mineral density (BMD)
Changes in hip and lumbar BMD from baseline
Changes from baseline in bone turnover markers
Morphometric vertebral fractures
Patients requiring a second ZOL
Relation between biomarker values and densitometry evolution
Relation between biomarker values and appearance of new vertebral fracture
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