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A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures
Sponsor: Odense University Hospital
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
Conditions
Interventions
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