Stopping Alendronate Treatment in Postmenopausal Women With Osteoporosis
Tests stopping alendronate versus continuing it in postmenopausal women with osteoporosis.
Plain-language title generated from the registry record
Registry title: A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures
Key facts
- Where
- Aalborg, Copenhagen, Esbjerg, Herlev, Hilleroed, Hvidovre, Odense C, and Toender, DenmarkSee the 8 sites
- Phase
- Phase 4
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Bispebjerg HospitalCopenhagen, DenmarkTaking people
- Esbjerg Og Grindsted SygehusEsbjerg, DenmarkTaking people
- Copenhagen University HospitalHerlev, DenmarkTaking people
- Nordsjaellands HospitalHilleroed, DenmarkTaking people
- Hvidovre HospitalHvidovre, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking people
- Region SyddanmarkToender, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Odense University Hospital
- Trial code
- NCT06864130EU 2023-510042-24-01
- Record updated
- 7 March 2025
- Original description
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:Read full original descriptionShow less
The Alendronate Discontinuation Study
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.
Inclusion: 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: Treatment with systemic glucocorticoids, ongoing or within 12 months; Uncontrolled inflammatory disease; Active malignancy; eGFR < 40 mL/min; T-score < - 3,5 in hip (total hip or femoral neck) or lumbar spine; Atypical femur fracture (ever); OsteoNecrosis of the Jaw (active); Unable to give inform consent.