A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures

What this trial studies

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.

Conditions in scope

• Osteoporosis in Post-menopausal Women

Interventions

• Alendronate 70mg weekly (Drug) — The intervention is discontinuation of Alendronate

Who can join

Women only · Adults (Child, Adult, Older Adult)

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: PHASE4
• Start date: 2025-02-21
• Primary completion: 2029-03-01
• Last update posted: 2025-03-07
• First posted: 2025-03-07

Sponsor & contact

Lead sponsor: Odense University Hospital (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Fragility fractures (From enrollment to the end of the 3 year study period.)
  Incidence of fragility fractures during the study period

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