Effects of stopping Alendronate in postmenopausal women with osteoporosis
The Alendronate Discontinuation Study
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 |
| Enrollment | 1400 (estimated) |
| Sex | Female |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 7 sites (Aalborg and 6 other locations) |
| Trial ID | NCT06864130 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women currently treated with Alendronate who have had no fractures during their treatment period.
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.
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 performed: Other studies have explored the effects of discontinuing osteoporosis treatments, but this specific approach to Alendronate discontinuation is relatively novel.
Eligibility criteria
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 this trial is running
Aalborg and 6 other locations
- 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)
- Hvidovre Hospital — Hvidovre, Denmark (Not_yet_recruiting)
- Odense University Hospital — Odense, Denmark (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.