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

NCT06864130 | Recruiting Phase 4

• 2 other identifiers: CT 2023-510042-242023-510042-24-01
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 7

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.

Conditions

Osteoporosis in Post-menopausal Women

Keywords

Alendronate; Discontinuation; Osteoporosis; Bone mineral density; post-menopausal

Outcome Measures

Primary Outcomes (1)

• Fragility fractures

  Incidence of fragility fractures during the study period

  From enrollment to the end of the 3 year study period.

Secondary Outcomes (5)

• Changes in bone mineral density (BMD)

  Baseline, 12, 24 and 36 months

• Bone turn over marker (CTX)

  Blood samples are performed at baseline, 6, 12, 18, 24, and 36 months.

• Bone turn over marker (P1NP)

  Blood samples are performed at baseline, 6, 12, 18, 24, and 36 months.

• Restart Criteria

  From enrollment to the end of the study period at 3 years

• Adverse Events

  From enrollment to the end of the 3 year study period.

Other Outcomes (3)

• Osteoclastassay

  Baseline and 12 months

• Molecular bone histology

  12 and 36 months

• Epigenetic analysis

  Baseline

Study Arms (2)

Discontinuation of Alendronate

EXPERIMENTAL

Discontinuation of Alendronate treatment

Drug: Alendronate 70mg weekly

Control group

NO INTERVENTION

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

Interventions

Alendronate 70mg weekly DRUG

The intervention is discontinuation of Alendronate

Discontinuation of Alendronate

Eligibility Criteria

• Gender Eligibility Details: Only biological females will be enrolled.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (7)

Aalborg University Hospital

Aalborg, 9000, Denmark

NOT YET RECRUITING

Bispebjerg Hospital

Copenhagen, 2400, Denmark

NOT YET RECRUITING

Esbjerg Og Grindsted Sygehus

Esbjerg, 6700, Denmark

NOT YET RECRUITING

Copenhagen University Hospital (Herlev)

Herlev, 2730, Denmark

NOT YET RECRUITING

Nordsjaellands Hospital (Hillerød)

Hillerød, 3400, Denmark

NOT YET RECRUITING

Hvidovre Hospital

Hvidovre, 2650, Denmark

NOT YET RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Pernille Hermann, MD, PhD.

  Odense Universitetshospital / Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pernille Hermann, MD, PhD.

CONTACT

+4523602366; pernille.herman@rsyd.dk

Lars Folkestad, MD, PhD.

CONTACT

+4529648537; lars.folkestad@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 7, 2025
• Study Start: February 21, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): September 15, 2029
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (7)