Actively Recruiting
StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis
Led by University Hospital, Toulouse · Updated on 2025-12-31
200
Participants Needed
17
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with post-menopausal osteoporosis
- Treated with denosumab for at least 2 years and with decision to stop denosumab after reaching therapeutic target defined by no fractures during treatment, no new risk factors, and no bone mineral density decrease greater than 0.03 g/cm² at spine or hip
- History of severe fracture or femoral or lumbar T-score less than or equal to -2.5 before starting denosumab
You will not qualify if you...
- Use of denosumab for bone diseases other than postmenopausal osteoporosis
- Uncontrolled endocrine diseases or liver failure
- Use of medications affecting bone metabolism in the past year including bisphosphonates, teriparatide, romosozumab, selective estrogen receptor modulators, breast cancer hormone therapy, or glucocorticoids over 5 mg/day
- Contraindications to bisphosphonates including chronic kidney disease with GFR stage greater than or equal to G3b or prior intolerance to zoledronic acid
- Inability to give informed consent or complete study forms; legal protection status
- Expected poor compliance, alcoholism, or drug addiction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Amiens Hospital
Amiens, France
Actively Recruiting
2
Bordeaux Hospital
Bordeaux, France
Actively Recruiting
3
Cahors Hospital
Cahors, France
Actively Recruiting
4
Dax Hospital
Dax, France
Actively Recruiting
5
Le Mans Hospital
Le Mans, France
Actively Recruiting
6
Lille Hospital
Lille, France
Not Yet Recruiting
7
Limoges Hospital
Limoges, France
Actively Recruiting
8
Marseille Hsopital
Marseille, France
Actively Recruiting
9
Montpellier Hospital
Montpellier, France
Actively Recruiting
10
Nice Hospital
Nice, France
Actively Recruiting
11
Orléans Hospital
Orléans, France
Actively Recruiting
12
Cochin Hospital
Paris, France
Actively Recruiting
13
Lariboisiere Hospital
Paris, France
Actively Recruiting
14
Poitiers Hospital
Poitiers, France
Actively Recruiting
15
Rennes Hospital
Rennes, France
Actively Recruiting
16
Saint Etienne Hospital
Saint-Etienne, France
Actively Recruiting
17
Toulouse Hospital
Toulouse, France
Actively Recruiting
Research Team
Y
Yannick DEGBOE, MD
CONTACT
C
Charline DAGUZAN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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