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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorOdense University Hospital

About this trial

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

Qualifiers

Female

Postmenopausal

Current treatment with Alendronate

Alendronate treatment >3 år AND no fracture OR

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Alendronate 70mg weekly

Treatment groups

1,400 Participants
are divided into 2 treatment groups

Sponsors and collaborators