Phase 2
Completed N=30
The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover
Erosive Osteoarthritis
Source: ClinicalTrials.gov NCT04403698 ↗
Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Dec 2024
Primary outcomePrimary: CTX-I (C-terminal Telopeptide of Type I Collagen ) Bone Turnover Marker Levels — 0.05; 0.06; 0.63; 0.33 ng/ml — p=<0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CTX-I (C-terminal Telopeptide of Type I Collagen ) Bone Turnover Marker Levels |
0.05; 0.06; 0.63; 0.33 | <0.01 sig |
| PRIMARY PINP (N-terminal Propeptide of Type I Procollagen) Bone Turnover Marker Levels |
8.1; 4.6; 78.9; 39.5 | 0.05 |
| SECONDARY Number of Patients With CTX-I (C-terminal Telopeptide of Type I Collagen )Levels Above the Reference Range at Week 48 |
5; 0 | 0.042 sig |
| SECONDARY The Number of Patients PINP (N-terminal Propeptide of Type I Procollagen) Above Reference Range at Week 48 |
5; 0 | 0.042 sig |
| SECONDARY Bone Mass Density at the Spine After 48 Weeks |
1.16; 1.11; 1.10; 1.11 | — |
| SECONDARY Bone Mass Density at the Hip After 48 Weeks |
0.85; 0.80; 0.85; 0.81 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04403698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.