At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
Alendronate Effervescent Oral Tabletdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Use of Buffered Soluble Alendronate 70 mg (Steovess/Binosto) After Denosumab Discontinuation to Prevent Increase in Bone Turnover
In Brief
A Phase 2 clinical trial evaluating Alendronate Effervescent Oral Tablet for Erosive Osteoarthritis. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErosive Osteoarthritis
CountriesBelgium
CollaboratorsAmgen, EffRx Pharmaceuticals SA
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartNov 2019
First PostedMay 2020
Primary CompletionMar 2022
TodayJul 2026
First PostedMay 27, 2020
Enrollment StartNov 13, 2019
Primary CompletionMar 9, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.1 years ago
Interventions
Alendronate Effervescent Oral Tabletdrug
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