The Alendronate Discontinuation Study

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aalborg University Hospital
NOT_YET_RECRUITING
Aalborg
Bispebjerg Hospital
NOT_YET_RECRUITING
Copenhagen
Esbjerg Og Grindsted Sygehus
NOT_YET_RECRUITING
Esbjerg
Copenhagen University Hospital (Herlev)
NOT_YET_RECRUITING
Herlev
Nordsjaellands Hospital (Hillerød)
NOT_YET_RECRUITING
Hillerød
Hvidovre Hospital
NOT_YET_RECRUITING
Hvidovre
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Pernille Hermann, MD, PhD.
pernille.herman@rsyd.dk
+4523602366
Backup
Lars Folkestad, MD, PhD.
lars.folkestad@rsyd.dk
+4529648537
Time Frame
Start Date: 2025-02-21
Estimated Completion Date: 2029-09-15
Participants
Target number of participants: 1400
Treatments
Experimental: Discontinuation of Alendronate
Discontinuation of Alendronate treatment
No_intervention: Control group
The control group will continue Alendronate treatment, but shift to project-sponsored product (70 mg Alendronate weekly)
Sponsors
Leads: Odense University Hospital

This content was sourced from clinicaltrials.gov