A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures
Recruiting
Phase 4
Interventional Study
Osteoporosis in Post-menopausal Women
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,400 (estimated)
- Sponsor
- Odense University Hospital · Other
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About This Trial
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…
Trial Locations
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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 spi…
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