NCT06864130 A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures
| NCT ID | NCT06864130 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Odense University Hospital |
| Condition | Osteoporosis in Post-menopausal Women |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2025-02-21 |
| Primary Completion | 2029-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,400 participants in total. It began in 2025-02-21 with a primary completion date of 2029-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to study the effects of discontinuation of Alendronate treatment for three years. The participants are postmenopausal women with osteoporosis, who have had a treatment period without fractures. The study will answer: * What is the rate of fragility fractures during the study? The hypothesis is that discontinuation of Alendronate after a fracture-free period does not raise the 3-year fracture risk. * Are there predictors of significant bone loss after discontinuation of Alendronate? The hypothesis is that clinical, biochemical, cellular, or molecular characteristics can predict bone loss. Researchers will compare the outcomes of discontinuation of Alendronate with continuing treatment. Participants will be randomly assigned to a group. Participants will: * Either take alendronate once weekly for three years OR discontinue their treatment * Visit the clinic at 6 and 18 months for blood samples * Visit the clinic at the start of the study and after 1, 2, and 3 years for bone scans and blood samples.
Eligibility Criteria
Inclusion Criteria: * Female * Postmenopausal * Current treatment with Alendronate * Alendronate treatment \>3 år AND no fracture OR * Alendronate treatment \>5 år AND latest low energy fracture \> 3 years ago Exclusion Criteria: * T-score \< - 3,5 in hip (total hip or femoral neck) or lumbar spine * Treatment with systemic glucocorticoids, ongoing or within 12 months * Uncontrolled inflammatory disease * Active malignancy * eGFR \< 40 mL/min * Atypical femur fracture (ever) * OsteoNecrosis of the Jaw (active) * Unable to give inform consent
Contact & Investigator
Pernille Hermann, MD, PhD.
PRINCIPAL INVESTIGATOR
Odense Universitetshospital / Odense University Hospital
Frequently Asked Questions
Who can join the NCT06864130 clinical trial?
This trial is open to female participants only, studying Osteoporosis in Post-menopausal Women. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06864130 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06864130 currently recruiting?
Yes, NCT06864130 is actively recruiting participants. Contact the research team at pernille.herman@rsyd.dk for enrollment information.
Where is the NCT06864130 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Copenhagen, Denmark, Esbjerg, Denmark, Herlev, Denmark and 3 additional locations.
Who is sponsoring the NCT06864130 clinical trial?
NCT06864130 is sponsored by Odense University Hospital. The principal investigator is Pernille Hermann, MD, PhD. at Odense Universitetshospital / Odense University Hospital. The trial plans to enroll 1,400 participants.