Clinical trial NCT06864130: A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures
Official title: The Alendronate Discontinuation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Osteoporosis in Post-menopausal Women
Keywords: Alendronate
Discontinuation
Osteoporosis
Bone mineral density
post-menopausal
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 1400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* T-score \< - 3,5 in hip (total hip or femoral neck) or lumbar spine
* Treatment with systemic glucocorticoids, ongoing or within 12 months
* Uncontrolled inflammatory disease
* Active malignancy
* eGFR \< 40 mL/min
* Atypical femur fracture (ever)
* OsteoNecrosis of the Jaw (active)
* Unable to give inform consent

Primary outcomes:
measure: Fragility fractures
timeFrame: From enrollment to the end of the 3 year study period.
Secondary outcomes:
measure: Changes in bone mineral density (BMD)
timeFrame: Baseline, 12, 24 and 36 months
measure: Bone turn over marker (CTX)
timeFrame: Blood samples are performed at baseline, 6, 12, 18, 24, and 36 months.
measure: Bone turn over marker (P1NP)
timeFrame: Blood samples are performed at baseline, 6, 12, 18, 24, and 36 months.
measure: Restart Criteria
timeFrame: From enrollment to the end of the study period at 3 years
measure: Adverse Events
timeFrame: From enrollment to the end of the 3 year study period.
Other outcomes:
measure: Osteoclastassay
timeFrame: Baseline and 12 months
measure: Molecular bone histology
timeFrame: 12 and 36 months
measure: Epigenetic analysis
timeFrame: Baseline
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Esbjerg
country: Denmark
facility: Esbjerg Og Grindsted Sygehus
city: Herlev
country: Denmark
facility: Copenhagen University Hospital (Herlev)
city: Hillerød
country: Denmark
facility: Nordsjaellands Hospital (Hillerød)
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense Universitetshospital / Odense University Hospital
name: Pernille Hermann, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: