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Alendronate in an Weekly Effervescent Tablet Formulation Following Denosumab Discontinuation

NCT04338529 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 92

Last updated 2024-12-02

No results posted yet for this study

Summary

Discontinuation of denosumab results in a rebound response of bone turnover markers, which rise above baseline at 3 months and remain elevated until reaching again baseline levels approximately 30 months after the last dose. Bone mineral density (BMD) gains are also lost and BMD values reach original baseline values after 1-2 years off-treatment.For the above reasons, current literature recommends that patients who discontinue denosumab should continue to receive either intravenous (iv) or oral (peros) bisphosphonate therapy for some time. The study aims to investigate changes in the BMD of the lumbar spine 12 months after transitioning from denosumab to oral alendronate 70 mg in a weekly effervescent tablet formulation

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Binosto 70Mg Effervescent Tablet

As discussed in group descriptions

Sponsors & Collaborators

  • Laikο General Hospital, Athens

    collaborator OTHER

  • 424 General Military Hospital

    collaborator OTHER

  • 251 Hellenic Air Force & VA General Hospital

    lead OTHER

Principal Investigators

  • Maria Yavropoulou, MD, PhD · LAIKO General Hospital, Athens, Greece

  • Polyzois Makras, MD, PhD · 251 Hellenic Airforce Gen. Hospital, Athens, Greece

  • Athanasios D Anastasilakis, MD, PhD · 424 Gen. Military Hospital Thessaloniki, Greece

Eligibility

Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2024-09-25
Completion
2024-11-01

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04338529 on ClinicalTrials.gov