Effects of stopping Alendronate in postmenopausal women with osteoporosis
Official title: The Alendronate Discontinuation Study
Run by Odense University Hospital · NCT06864130 · Data updated 2026-11-12
This study is testing what happens to postmenopausal women with osteoporosis when they stop taking Alendronate, to see if they have more fractures or bone loss compared to those who keep taking it.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Sex | Women only |
| Enrollment | 1400 (estimated) |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 7 sites (Aalborg and 6 other locations) |
| Status | Recruiting |
| Started | February 21, 2025 |
| Main results expected | March 1, 2029 |
| Study ends | September 15, 2029 |
| Registry record updated | March 7, 2025 |
| Trial ID | NCT06864130 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are postmenopausal women currently treated with Alendronate who have had no fractures during their treatment period.
✕Probably not a fit
Patients with severe osteoporosis or those who have had recent fractures or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the impact of discontinuing Alendronate treatment in postmenopausal women with osteoporosis who have not experienced fractures during their treatment. Participants will be randomly assigned to either continue Alendronate or stop the treatment for three years. The study aims to determine the rate of fragility fractures and identify predictors of significant bone loss after stopping the medication. Participants will undergo regular clinic visits for monitoring and blood sample collection.
Why it matters
Potential benefit: If successful, this study could help determine safe treatment strategies for postmenopausal women with osteoporosis, potentially reducing unnecessary medication use.
How similar studies have gone: Other studies have explored the effects of discontinuing osteoporosis treatments, but this specific approach to Alendronate discontinuation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Odense University Hospital
Odense, Denmark Recruiting -
Aalborg University Hospital
Aalborg, Denmark Not yet recruiting -
Bispebjerg Hospital
Copenhagen, Denmark Not yet recruiting -
Esbjerg Og Grindsted Sygehus
Esbjerg, Denmark Not yet recruiting -
Copenhagen University Hospital (Herlev)
Herlev, Denmark Not yet recruiting -
Nordsjaellands Hospital (Hillerød)
Hillerød, Denmark Not yet recruiting
Show 1 more location
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Hvidovre Hospital
Hvidovre, Denmark Not yet recruiting
Study contacts
- Principal investigator: Pernille Hermann, MD, PhD. — Odense Universitetshospital / Odense University Hospital
- Study coordinator: Pernille Hermann, MD, PhD.
- Email: pernille.herman@rsyd.dk
- Phone: +4523602366
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Impact of Mother-of-pearl Supplement on Preventing Osteoporosis in Post-menopausal Women
This study tests whether taking mother-of-pearl supplements can help prevent osteoporosis in post-menopausal women aged 50 to 65 who are at risk for the condition.
-
Hydration in women across life stages
This study tests how well water and electrolyte drinks rehydrate women at different life stages after overnight fasting and fluid restriction.
-
Dairy Choline Availability: Is WPPC a match for eggs in postmenopausal women?
This study tests whether whey protein phospholipid concentrate (WPPC) provides choline as well as whole eggs for postmenopausal women.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.