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Skeletal hyperostosis in patients receiving chronic, very-low-dose isotretinoin
J A Tangrea1, R F Kilcoyne, P R Taylor
1Division of Cancer Prevention and Control, National Cancer Institute, National Institutes of Health, Bethesda, Md.
Background And Design:
We conducted a prospective roentgenographic survey of patients participating in a randomized, placebo-controlled, multicenter clinical trial that evaluated the effectiveness of chronic, very-low-dose (approximately 0.14 mg/kg per day for 3 years) isotretinoin in preventing the subsequent occurrences of new basal cell carcinoma in patients with previous basal cell carcinoma. To assess potential skeletal changes, a sample of 269 patients from among a total of 981 enrollees were randomly selected for comparative roentgenographic review. Baseline and 36-month roentgenograms of the cervical and thoracic spine of each patient were read side by side by a radiologist, masked to treatment group, who noted both the presence and extent of abnormalities at each vertebral level at baseline and the progression of existing or occurrence of new abnormalities at previously unaffected levels at 36 months.
Results:
In comparison with the placebo group, significantly more patients in the isotretinoin group exhibited progression of existing hyperostotic abnormalities (40% vs 18%; P less than .001) and new hyperostotic involvement at previously unaffected vertebral levels (8% vs 1%; P = .015).
Conclusion:
Our findings indicate that chronic, very-low-dose isotretinoin can induce hyperostotic axial skeletal changes similar to those reported in patients taking higher doses.
Insights
Chronic, very-low-dose isotretinoin use in patients with a history of basal cell carcinoma was associated with increased hyperostotic axial skeletal changes. These findings suggest isotretinoin may induce bone abnormalities even at low doses.
Area of Science:
- Dermatology
- Orthopedics
- Radiology
Background:
- A randomized, placebo-controlled trial investigated the efficacy of chronic, very-low-dose isotretinoin in preventing new basal cell carcinoma.
- The study assessed potential skeletal changes associated with this long-term, low-dose isotretinoin regimen.
Purpose of the Study:
- To evaluate the impact of chronic, very-low-dose isotretinoin on axial skeletal changes.
- To compare the incidence of hyperostotic abnormalities in patients receiving isotretinoin versus placebo.
Main Methods:
- A prospective roentgenographic survey was conducted on a subset of patients from a larger clinical trial.
- 269 patients were randomly selected for comparative roentgenographic review of the cervical and thoracic spine.
- Radiologists masked to treatment groups analyzed baseline and 36-month roentgenograms for skeletal abnormalities and progression.
Main Results:
- Patients in the isotretinoin group showed significantly more progression of existing hyperostotic abnormalities (40% vs 18%; P < .001).
- New hyperostotic involvement at previously unaffected vertebral levels was also significantly higher in the isotretinoin group (8% vs 1%; P = .015).
Conclusions:
- Chronic, very-low-dose isotretinoin administration can induce hyperostotic axial skeletal changes.
- These changes are similar to those observed in patients treated with higher doses of isotretinoin.