Prevention of glucocorticoid-induced osteoporosis in immunobullous diseases with alendronate: A randomized, double-blind, placebo-controlled study

Shang Ian Tee, Gil Yosipovitch, Yuin Chew Chan, Sze Hon Chua, Ee Tzun Koh, Yiong Huak Chan, Susanna Soo See Tan, Ian Yu Yan Tsou, Suat Hoon Tan

Research output: Contribution to journalArticle

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Abstract

Objective: To evaluate the efficacy and safety of oral alendronate sodium therapy once daily in preventing glucocorticoid-induced bone loss in patients with immunobullous skin diseases treated with long-term glucocorticoid therapy. Design: A 12-month randomized, double-blind, placebocontrolled trial. Setting:Atertiary referraldermatologycenter in Singapore. Participants: Patients newly diagnosed as having an immunobullous disease and deemed to require at least 6 months of systemic glucocorticoid therapy. Interventions: The patients were randomized to receive either oral alendronate sodium (10 mg/d) or amatching placebo for 12 months. All patients also received concurrent calcium with vitamin D, 2 tablets daily. Main Outcome Measures: Percent change in bone mineral density (BMD) at the lumbar spine and the femoral neck at 12 months. Results: A total of 29 patients (alendronate [n=15], placebo [n=14]) were evaluated. The percent change inBMD in the alendronate group was +3.7% and +3.5% at the lumbar spine and the femoral neck, respectively, whereas in the placebo group, it was -1.4% and -0.7% at the lumbar spine and the femoral neck, respectively. The increase in BMD observed in the alendronate group compared with the placebo group was statistically significant at both the lumbar spine (P=.01) and the femoral neck (P=.01). There was also a statistically significant decrease in serum heat-labile alkaline phosphatase levels after 12 months (-32.6%, P≲λτ∀.01) in the alendronate group but not in the placebo group. Adverse events were generally minor, and the frequency of occurrence did not differ significantly between both treatment groups (P=.59). Conclusions: There were statistically significant increases in BMD at both the lumbar spine (P=.01) and the femoral neck (P=.01) with alendronate therapy. It is imperative to use bisphophonate therapy in patients with immunobullous disorders who are receiving oral corticosteroids because it largely prevents themorbidity associated with low BMD.

Original languageEnglish (US)
Pages (from-to)307-314
Number of pages8
JournalArchives of Dermatology
Volume148
Issue number3
DOIs
StatePublished - Mar 1 2012
Externally publishedYes

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Alendronate
Glucocorticoids
Osteoporosis
Femur Neck
Placebos
Spine
Bone Density
Therapeutics
Ergocalciferols
compound A 12
Singapore
Skin Diseases
Tablets
Alkaline Phosphatase
Adrenal Cortex Hormones
Hot Temperature
Outcome Assessment (Health Care)
Calcium
Safety
Bone and Bones

ASJC Scopus subject areas

  • Dermatology

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Prevention of glucocorticoid-induced osteoporosis in immunobullous diseases with alendronate : A randomized, double-blind, placebo-controlled study. / Tee, Shang Ian; Yosipovitch, Gil; Chan, Yuin Chew; Chua, Sze Hon; Koh, Ee Tzun; Chan, Yiong Huak; Tan, Susanna Soo See; Tsou, Ian Yu Yan; Tan, Suat Hoon.

In: Archives of Dermatology, Vol. 148, No. 3, 01.03.2012, p. 307-314.

Research output: Contribution to journalArticle

Tee, Shang Ian ; Yosipovitch, Gil ; Chan, Yuin Chew ; Chua, Sze Hon ; Koh, Ee Tzun ; Chan, Yiong Huak ; Tan, Susanna Soo See ; Tsou, Ian Yu Yan ; Tan, Suat Hoon. / Prevention of glucocorticoid-induced osteoporosis in immunobullous diseases with alendronate : A randomized, double-blind, placebo-controlled study. In: Archives of Dermatology. 2012 ; Vol. 148, No. 3. pp. 307-314.
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abstract = "Objective: To evaluate the efficacy and safety of oral alendronate sodium therapy once daily in preventing glucocorticoid-induced bone loss in patients with immunobullous skin diseases treated with long-term glucocorticoid therapy. Design: A 12-month randomized, double-blind, placebocontrolled trial. Setting:Atertiary referraldermatologycenter in Singapore. Participants: Patients newly diagnosed as having an immunobullous disease and deemed to require at least 6 months of systemic glucocorticoid therapy. Interventions: The patients were randomized to receive either oral alendronate sodium (10 mg/d) or amatching placebo for 12 months. All patients also received concurrent calcium with vitamin D, 2 tablets daily. Main Outcome Measures: Percent change in bone mineral density (BMD) at the lumbar spine and the femoral neck at 12 months. Results: A total of 29 patients (alendronate [n=15], placebo [n=14]) were evaluated. The percent change inBMD in the alendronate group was +3.7{\%} and +3.5{\%} at the lumbar spine and the femoral neck, respectively, whereas in the placebo group, it was -1.4{\%} and -0.7{\%} at the lumbar spine and the femoral neck, respectively. The increase in BMD observed in the alendronate group compared with the placebo group was statistically significant at both the lumbar spine (P=.01) and the femoral neck (P=.01). There was also a statistically significant decrease in serum heat-labile alkaline phosphatase levels after 12 months (-32.6{\%}, P≲λτ∀.01) in the alendronate group but not in the placebo group. Adverse events were generally minor, and the frequency of occurrence did not differ significantly between both treatment groups (P=.59). Conclusions: There were statistically significant increases in BMD at both the lumbar spine (P=.01) and the femoral neck (P=.01) with alendronate therapy. It is imperative to use bisphophonate therapy in patients with immunobullous disorders who are receiving oral corticosteroids because it largely prevents themorbidity associated with low BMD.",
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AU - Chua, Sze Hon

AU - Koh, Ee Tzun

AU - Chan, Yiong Huak

AU - Tan, Susanna Soo See

AU - Tsou, Ian Yu Yan

AU - Tan, Suat Hoon

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N2 - Objective: To evaluate the efficacy and safety of oral alendronate sodium therapy once daily in preventing glucocorticoid-induced bone loss in patients with immunobullous skin diseases treated with long-term glucocorticoid therapy. Design: A 12-month randomized, double-blind, placebocontrolled trial. Setting:Atertiary referraldermatologycenter in Singapore. Participants: Patients newly diagnosed as having an immunobullous disease and deemed to require at least 6 months of systemic glucocorticoid therapy. Interventions: The patients were randomized to receive either oral alendronate sodium (10 mg/d) or amatching placebo for 12 months. All patients also received concurrent calcium with vitamin D, 2 tablets daily. Main Outcome Measures: Percent change in bone mineral density (BMD) at the lumbar spine and the femoral neck at 12 months. Results: A total of 29 patients (alendronate [n=15], placebo [n=14]) were evaluated. The percent change inBMD in the alendronate group was +3.7% and +3.5% at the lumbar spine and the femoral neck, respectively, whereas in the placebo group, it was -1.4% and -0.7% at the lumbar spine and the femoral neck, respectively. The increase in BMD observed in the alendronate group compared with the placebo group was statistically significant at both the lumbar spine (P=.01) and the femoral neck (P=.01). There was also a statistically significant decrease in serum heat-labile alkaline phosphatase levels after 12 months (-32.6%, P≲λτ∀.01) in the alendronate group but not in the placebo group. Adverse events were generally minor, and the frequency of occurrence did not differ significantly between both treatment groups (P=.59). Conclusions: There were statistically significant increases in BMD at both the lumbar spine (P=.01) and the femoral neck (P=.01) with alendronate therapy. It is imperative to use bisphophonate therapy in patients with immunobullous disorders who are receiving oral corticosteroids because it largely prevents themorbidity associated with low BMD.

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