The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover (NCT04403698) | Clinical Trial Compass
CompletedPhase 2
The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover
Belgium30 participantsStarted 2019-11-13
Plain-language 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.
Who can participate
Age range30 Years
SexALL
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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.
What they're measuring
1
CTX-I (C-terminal Telopeptide of Type I Collagen ) Bone Turnover Marker Levels
Timeframe: 48 weeks
2
PINP (N-terminal Propeptide of Type I Procollagen) Bone Turnover Marker Levels