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New treatment option for Postmenopausal Osteoporosis
Official title StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis
ClinicalTrials.gov ID: NCT06767150
What this study is testing
What is a second infusion of ZOL when crosslaps levels reach 300 pg/mL?
a second infusion of ZOL when crosslaps levels reach 300 pg/mL is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for postmenopausal osteoporosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women with post-menopausal osteoporosis
- And treated with denosumab for at least 2 years and reaching decision of denosumab withdrawal because of achieved therapeutic target defined as no...
- And with a history of severe fracture or a femoral or lumbar T-score ≤ -2.5 prior denosumab initiation.
You likely can't join if
- Dmab use for bone disease other than post-menopausal osteoporosis.
- Uncontrolled endocrine diseases. Liver failure.
- Use of medication affecting bone metabolism during the last year, including bisphosphonates, teriparatide, romosozumab, Selective Estrogen Receptor...
- Contra-indication to bisphosphonates according to license recommendation including chronic kidney disease with GFR stage \> or = G3b. Prior...
- people unable to give an informed consent or to fill the case report form. people under law protection.
- Foreseeable poor compliance with the strategy, alcoholism, toxicomania.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Bordeaux, France
- Cahors, France
- Dax, France
- Le Mans, France
- Lille, France
- Limoges, France
- Marseille, France
- Montpellier, France
- Nice, France
- Orléans, France
- Paris, France
- Poitiers, France
- Rennes, France
- Saint-Etienne, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Bordeaux, France; Cahors, France; Dax, France; Le Mans, France; Lille, France and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.