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

NCT06864130 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2025-03-07

No results posted yet for this study

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.

Conditions

  • Osteoporosis in Post-menopausal Women

Interventions

DRUG

Alendronate 70mg weekly

The intervention is discontinuation of Alendronate

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Pernille Hermann, MD, PhD. · Odense Universitetshospital / Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-21
Primary Completion
2029-03-01
Completion
2029-09-15

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06864130 on ClinicalTrials.gov