A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women with Osteoporosis After a Treatment Period Without Fractures (ALEXIS)

Odense University Hospital

Status and phase: Enrolling; Phase 4

Conditions: Osteoporosis in Post-menopausal Women

Treatments: Drug: Alendronate 70mg weekly

Study type: Interventional

Funder types: Other

Identifiers

NCT06864130

2023-510042-24-01 (EU Trial (CTIS) Number)

CT 2023-510042-24

Details and patient eligibility

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.

Enrollment: 1,400 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,400 participants in 2 patient groups

Discontinuation of Alendronate

Experimental group

Description:

Discontinuation of Alendronate treatment

Treatment:

Drug: Alendronate 70mg weekly

Control group

No Intervention group

Description:

The control group will continue Alendronate treatment, but shift to project-sponsored product (70 mg Alendronate weekly)