No overshoot of bone turnover after withdrawal of denosumab treatment of adults with Langerhans cell histiocytosis: a prospective clinical trial
Authors' conclusion
Dmab withdrawal in patients with LCH was not followed by an overshoot of bone turnover markers or bone loss despite the administration in 6 months of a total dose equal to that given in osteoporosis for 4 years. Total Dmab dose is, thus, not an important determinant of the bone turnover overshoot after treatment withdrawal.
Study context
- Population
- Adults with Langerhans cell histiocytosis (LCH); 8 with bone lesions (4 single, 4 multiple), 2 without
- Participants
- 10 adults
- Outcome
- Peak bone turnover markers after Dmab withdrawal vs baseline
- Follow-up
- 24 months after last injection
Methodological detailsopen label, phase 2b
- Open label
- Phase 2b
Main finding
As reported in the abstract
Peak serum CTX after treatment arrest, mean ± SD (not significantly different from baseline, p = 0.11)
0.522 ± 0.366 ng/mL
Peak P1NP after treatment arrest, mean ± SD (not significantly different from baseline, p = 0.65)
72.2 ± 35.9 ng/mL
Observational data: associations, not effects.
Further findings
Correlation of pretreatment and peak serum CTX
- Spearman rs (p = 0.007)
- 0.818
Safety
- No vertebral fractures, bone loss, or hypercalcemia were observed
Original publication
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