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The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover

NCT04403698 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-13

Study results available
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Summary

It is hypothesized that effervescent alendronate will be able to maintain bone turnover markers within the pre-menopausal reference range and thereby reducing the likelihood of bone turnover associated changes (rebound effect), after discontinuation of denosumab treatment in a non-osteoporotic population.

Conditions

  • Erosive Osteoarthritis

Interventions

DRUG

Alendronate Effervescent Oral Tablet

At the earliest three months but no later than four months after the last denosumab injection, subjects will be randomized to effervescent alendronate administered for either 24 or 48 weeks

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • EffRx Pharmaceuticals SA

    collaborator INDUSTRY

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Ruth Wittoek, Prof. dr. · Ghent Universitary Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2022-03-09
Completion
2022-03-09

Countries

  • Belgium

Study Locations

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Entities

Companies

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 NCT04403698 on ClinicalTrials.gov