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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for postmenopausal women with osteoporosis who are taking alendronate and have had no recent fractures. It tests stopping alendronate versus continuing it for three years.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Postmenopausal women with osteoporosis who have had a period on treatment without fractures
- Earlier treatment
- Currently taking alendronate. Either more than 3 years of treatment with no fracture, or more than 5 years of treatment with the latest low energy fracture more than 3 years ago.
Main reasons for not taking part
- T-score below -3,5 in the hip (total hip or femoral neck) or lumbar spine
- Systemic glucocorticoid treatment, ongoing or within 12 months
- Uncontrolled inflammatory disease or active malignancy
- eGFR below 40 mL/min
- Ever had an atypical femur fracture, or active osteonecrosis of the jaw
Read by machine on 12 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.