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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-21

Study Completion Date

2029-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis in Post-menopausal Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Discontinuation of Alendronate

Discontinuation of Alendronate treatment

Group Type EXPERIMENTAL

Alendronate 70mg weekly

Intervention Type DRUG

The intervention is discontinuation of Alendronate

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Alendronate 70mg weekly

The intervention is discontinuation of Alendronate

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pernille Hermann, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Odense Universitetshospital / Odense University Hospital

Locations

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