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

Launched by UNIVERSITY HOSPITAL, GHENT · May 25, 2020

Keywords

ClinConnect Summary

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 postmenopausal osteoporosis back to background levels. However, no excess in fracture incidence was observed. Amongst patients who presented with vertebral fractures after treatment discontinuation, there was a slightly higher incidence of multiple vertebral fractures in patients discontinuing Prolia versus those who discontinued the placebo treatment.

A 2 year, randomized, crossover study demonstrated tha...

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Eligibility 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.