Status:
COMPLETED
The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Amgen
EffRx Pharmaceuticals SA
Conditions:
Erosive Osteoarthritis
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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 associate...
Detailed Description
Denosumab discontinuation is associated with a rebound effect in bone turnover and loss in bone mass density. These changes resulted in an increase of fracture incidence in patients with postmenopausa...
Eligibility Criteria
Inclusion
- Subjects must have completed the 48 weeks of the randomised placebo-controlled study phase followed by the 96 weeks open label denosumab 60 mg SC every 3 months phase. (EudraCT number: 2015-003223-53)
- Last denosumab injection minimal 3 months or maximum 4 months before baseline
- Able and willing to give written informed consent and to comply with the requirements of the study protocol
Exclusion
- Patients with clinically significant hypersensitivity to any of the components of effervescent alendronate.
- Patient who is pregnant or planning pregnancy
- Female subjects who are breast-feeding.
- History of osteonecrosis of the jaw, and/or recent (within 3 months) tooth extraction or other unhealed dental surgery; or planned invasive dental work during the study
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- Hypocalcaemia.
- Oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastro-intestinal disease such as peptic ulcer, or active gastro-intestinal bleeding, or surgery of the upper gastro-intestinal tract other than pyloroplasty.
- Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia.
- Inability to stand or sit upright for at least 30 minutes.
Key Trial Info
Start Date :
November 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04403698
Start Date
November 13 2019
End Date
March 9 2022
Last Update
December 13 2024
Active Locations (1)
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1
Ghent University Hospital
Ghent, Belgium, 9000