Last reviewed · How we verify
NCT06767150: SAFEST
StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis
Phase 4 trial testing a second infusion of ZOL when crosslaps levels reach 300 pg/mL in Postmenopausal Osteoporosis in 200 participants. Currently enrolling.
1 October 2030
Quick facts
| Lead sponsor | University Hospital, Toulouse |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 2 October 2025 |
| Primary completion | 1 October 2030 |
| Estimated completion | 1 October 2030 |
| Sites | 17 locations across France |
Drugs / interventions tested
- a second infusion of ZOL when crosslaps levels reach 300 pg/mL — full drug profile →
- a rescue second infusion at month-12 (standard traitment) — full drug profile →
Conditions studied
- Postmenopausal Osteoporosis — all drugs for Postmenopausal Osteoporosis →
Sponsor
University Hospital, Toulouse
Who can join
18 and older, female only, with Postmenopausal Osteoporosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Maintain lumbar bone mineral density (BMD) after 1 year of ZOL
Time frame: 1 year after inclusion
The proportion of patients who failed to maintain lumbar BMD after 1 year of ZOL according to the Least Significant Change (LSC) criterion
Sponsor's own description
Denosumab (Dmab) is a treatment for postmenopausal osteoporosis. However, its withdrawal is associated with a rebound phenomenon associated with an unexpected increased risk of vertebral fractures. Defining the optimal strategy for Dmab withdrawal is critically needed. Investigator propose an open-label randomized superiority strategy trial to compare the 1-year lumbar densitometric efficacy of biomarkers-driven zoledronate (ZOL) infusion vs standardized ZOL treatment to mitigate rebound phenomenon.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06767150
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Postmenopausal Osteoporosis
Currently open trials in the same condition.
- NCT05010590 — Anabolic Therapy in Postmenopausal Osteoporosis · Phase 4 · active not recruiting
- NCT02822378 — Dried Plums and Bone Health in Postmenopausal Women · NA · active not recruiting
Other University Hospital, Toulouse trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06767150 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Toulouse
- Last refreshed: 23 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06767150.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing