Actively Recruiting
A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures
Led by Odense University Hospital · Updated on 2025-03-07
1400
Participants Needed
7
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Postmenopausal
- Currently receiving treatment with Alendronate
- Alendronate treatment for more than 3 years without fractures OR
- Alendronate treatment for more than 5 years with the most recent low energy fracture more than 3 years ago
You will not qualify if you...
- T-score less than -3.5 in the hip (total hip or femoral neck) or lumbar spine
- Treatment with systemic glucocorticoids ongoing or within the past 12 months
- Uncontrolled inflammatory disease
- Active malignancy
- Estimated glomerular filtration rate less than 40 mL/min
- History of atypical femur fracture
- Active OsteoNecrosis of the Jaw
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Not Yet Recruiting
2
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Not Yet Recruiting
3
Esbjerg Og Grindsted Sygehus
Esbjerg, Denmark, 6700
Not Yet Recruiting
4
Copenhagen University Hospital (Herlev)
Herlev, Denmark, 2730
Not Yet Recruiting
5
Nordsjaellands Hospital (Hillerød)
Hillerød, Denmark, 3400
Not Yet Recruiting
6
Hvidovre Hospital
Hvidovre, Denmark, 2650
Not Yet Recruiting
7
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
Research Team
P
Pernille Hermann, MD, PhD.
CONTACT
L
Lars Folkestad, MD, PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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