Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06864130
PHASE4

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

Sponsor: Odense University Hospital

View on ClinicalTrials.gov

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.

Official title: The Alendronate Discontinuation Study

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

1400

Start Date

2025-02-21

Completion Date

2029-09-15

Last Updated

2025-03-07

Healthy Volunteers

No

Interventions

DRUG

Alendronate 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