A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteopor… (NCT06864130) | Clinical Trial Compass
RecruitingPhase 4
A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures
Denmark1,400 participantsStarted 2025-02-21
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fragility fractures
Timeframe: From enrollment to the end of the 3 year study period.