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

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Collaborators: Amgen; EffRx Pharmaceuticals
• Treatments: Alendronate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.