Effect of a single course of isotretinoin therapy on bone mineral density in adolescent patients with severe, recalcitrant, nodular acne - 24/08/11
, Craig B. Langman, MD b, Eduardo H. Tschen, MD c, Terry Jones, MD d, Alan Menter, MD e, Nicholas J. Lowe, MD f, Lawrence Eichenfield, MD g, Adelaide A. Hebert, MD h, David Pariser, MD i, Ronald P. Savin, MD j, Stacy R. Smith, MD k, Michael Jarratt, MD k, David Rodriguez, MD l, Dan K. Chalker, MD m, Steven Kempers, MD n, Mark Ling, MD o, Elyse S. Rafal, MD p, Sabra Sullivan, MD, PhD q, Sewon Kang, MD r, Leena P. Shah, PharmD s, Emily Wu, PharmD s, Julie Newhouse, PharmD s, Jonathan Pak, PharmD s, Douglas R. Eberhardt, MS, MBA s, Graeme F. Bryce, PhD s, John A. McLane, PhD s, Michael Ondovik, PharmD s, Catherine Chin, BSc s, Ko-Chin Khoo, MS s, Phoebe Rich, MD t
Reprint requests: John J. DiGiovanna, MD, Division of Dermatopharmacology, Department of Dermatology, Brown Medical School/Rhode Island Hospital, JBS-1, 593 Eddy St, Providence, RI 02903.Providence, Rhode Island; Chicago, Illinois; Albuquerque, New Mexico; Bryan, Dallas, Houston, and Austin, Texas; Los Angeles, San Diego, and La Jolla, California; Newport News, Virginia; New Haven, Connecticut; Miami, Florida; Augusta and Newman, Georgia; Fridley, Minnesota; Stony Brook, New York; Jackson, Mississippi; Ann Arbor, Michigan; Nutley, New Jersey; and Portland, Oregon
Abstract |
Background |
Adverse changes in bone have been reported for patients undergoing high-dose, long-term (several years) isotretinoin therapy for disorders of cornification. The effect of short-term (4-5 months) therapy at the lower dose recommended for acne on bone development in younger, growing adolescent (12-17 years) patients has not been well studied.
Objective |
The purpose of the study was to evaluate the effect of a standard, single course of isotretinoin (Accutane) therapy on bone mineral density (BMD) of the lumbar spine and hip in adolescents ages 12 to 17 years with severe, recalcitrant, nodular acne.
Methods |
In this open-label, multicenter study, 217 adolescents (81 girls) with severe, recalcitrant, nodular acne were enrolled and treated with isotretinoin twice daily with food at the recommended total dose of approximately 1 mg/kg for 16 to 20 weeks. BMD in the lumbar spine and hip was measured at baseline and at the end of therapy by dual energy radiograph absorptiometry.
Results |
There was no clinically significant mean change in BMD measured at the lumbar spine (+1.4%, range: −4.9% to +12.3%) or total hip (−0.26%, range: −11.3% to +15.0%). Hyperostosis was not observed in any patient. Typical efficacy expected in the treatment of acne was observed.
Conclusions |
A 16- to 20-week course of isotretinoin treatment at the recommended dose for severe acne has no clinically significant effect on lumbar spine and total hip BMD in the adolescent (12-17 years) population.
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 | Disclosures: All coauthors were supported by Roche for this study. Dr DiGiovanna has received honoraria and travel support from Hoffmann-La Roche, and grant support from Hoffmann-La Roche and Allergan, companies with an interest in systemic retinoids for acne. Dr DiGiovanna has served as a consultant to Hoffmann-La Roche. In addition, Dr DiGiovanna has received honoraria, travel, and grant support from companies with an interest in other, general acne medications. Dr Langman has served as a consultant to Roche. Drs Tschen and Jones have received grant support from Allergan. Dr Menter has received grant support and been a consultant to Allergan. Dr Lowe has received research grants from Roche. Dr Eichenfield has received grant support from Roche. Drs Hebert and Pariser have no additional disclosures. Dr Savin has received grant support from Roche and Allergan. Dr Smith has received grant support from Hoffmann La Roche and Allergan, companies with an interest in systemic retinoids for acne. In addition, Dr Smith has received honoraria, travel, and grant support from companies with an interest in other, general acne medications. Dr Jarratt has no additional disclosures. Dr Rodriquez has received grant support from Hoffmann La Roche and honoraria, travel, and grant support from Allergan, companies with an interest in systemic retinoids for acne. In addition, Dr Rodriquez has received honoraria, travel, and grant support from companies with an interest in other, general acne medications. Dr Chalker has been a consultant for Roche and Arriva Pharmaceuticals, and owns stock in Genzyme and Wyeth. Dr Kempers has no additional disclosures. Dr Ling has received research grant support from Roche and Allergan; Roche speakers' bureau. Dr Rafal has received grant support from Roche and Allergan. Dr Rafal has received honoraria, travel, and grant support from companies with an interest in other, general acne medications. Dr Sullivan has received honoraria and travel support from Roche. Dr Kang has no additional disclosures. Drs Shah, Wu, Pak, Eberhardt, Bryce, McLane, Ondovik, Chin, and Khoo were employees of Roche. Dr Newhouse was a Roche postdoctoral fellow. Dr Rich has no additional disclosures. Presented as a poster at the 60th Annual Meeting of the American Academy of Dermatology, New Orleans, Louisiana, Feb 22-27, 2002. |
Vol 51 - N° 5
P. 709-717 - novembre 2004 Retour au numéro
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