RecruitingPhase 4NCT06864130

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

The Alendronate Discontinuation Study


Sponsor

Odense University Hospital

Enrollment

1,400 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALE

Inclusion Criteria5

  • 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 Criteria8

  • 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

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Interventions

DRUGAlendronate 70mg weekly

The intervention is discontinuation of Alendronate


Locations(7)

Aalborg University Hospital

Aalborg, Denmark

Bispebjerg Hospital

Copenhagen, Denmark

Esbjerg Og Grindsted Sygehus

Esbjerg, Denmark

Copenhagen University Hospital (Herlev)

Herlev, Denmark

Nordsjaellands Hospital (Hillerød)

Hillerød, Denmark

Hvidovre Hospital

Hvidovre, Denmark

Odense University Hospital

Odense, Denmark

View Full Details on ClinicalTrials.gov

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NCT06864130