Five year study of etidronate and/or calcium as prevention and treatment for osteoporosis and fractures in patients with asthma receiving long term oral and/or inhaled glucocorticoids

I A Campbell, J G Douglas, R M Francis, R J Prescott, D M Reid, Res Comm British Thoracic Soc

Research output: Contribution to journalArticle

48 Citations (Scopus)

Abstract

Background: Glucocorticoids are associated with a reduction in bone density and an increased risk of fracture. Concurrent treatment with bisphosphonates reduces bone loss and may prevent fractures. A randomised study was performed to determine whether treatment with cyclical etidronate and/or calcium for 5 years prevents fractures or reverses/reduces bone loss in patients receiving glucocorticoid treatment for asthma.

Methods: A multicentre, randomised, parallel group comparison of etidronate alone, calcium alone, etidronate + calcium, and no treatment, with stratification according to level of glucocorticoid exposure was carried out in 39 chest clinics in the UK. Three hundred and forty nine postmenopausal female and male outpatients with asthma aged 50 - 70 years were randomised. The main outcome measures were fractures and changes in bone mineral density (BMD).

Results: Overall, 8% of the patients experienced symptomatic fractures and 17.5% developed either a symptomatic fracture and/or a semiquantitative vertebral fracture by the end of 5 years There were no significant differences between the four treatment groups. Comparing etidronate with no etidronate, the rates of new fractures were not significantly different for symptomatic fractures ( OR 1.07 ( 95% CI 0.46 to 2.47)) or for any fractures ( OR 0.82 ( 95% CI 0.45 to 1.47)). For the comparison of calcium with no calcium the corresponding ORs were 1.43 ( 95% CI 0.62 to 3.33) and 0.91 ( 95% CI 0.50 to 1.63). In post hoc analysis the effect of etidronate was greater in women than in men ( interaction p value 0.02) with the fracture incidence roughly halved ( OR 0.39, 95% CI 0.14 to 0.99). Etidronate increased BMD at the lumbar spine by 4.1% ( p = 0.001) while calcium had no significant effect. At the proximal femur the effects of treatment were not significant ( relative increases etidronate 1.6%; calcium 1.1%). The rate of new fractures in patients with fractures at entry (23.7%) was higher than in those without fractures at entry (14.3%): OR 1.87 ( 95% CI 1.06 to 3.07). No association was found between change in BMD and new fractures.

Conclusions: In patients receiving glucocorticoids for asthma etidronate significantly increased BMD over 5 years at the lumbar spine but not at the hip and had little if any protective effect against fractures, except possibly in postmenopausal women. The effects of calcium were not significant. Combination treatment had no advantage but increased unwanted effects.

Original languageEnglish
Pages (from-to)761-768
Number of pages8
JournalThorax
Volume59
DOIs
Publication statusPublished - 2004

Keywords

  • INTERMITTENT CYCLICAL ETIDRONATE
  • BONE-MINERAL DENSITY
  • STEROID-INDUCED OSTEOPOROSIS
  • VERTEBRAL FRACTURE
  • POSTMENOPAUSAL OSTEOPOROSIS
  • DOUBLE-BLIND
  • BECLOMETHASONE DIPROPIONATE
  • CORTICOSTEROIDS
  • RISK
  • THERAPY

Cite this

Five year study of etidronate and/or calcium as prevention and treatment for osteoporosis and fractures in patients with asthma receiving long term oral and/or inhaled glucocorticoids. / Campbell, I A ; Douglas, J G ; Francis, R M ; Prescott, R J ; Reid, D M ; Res Comm British Thoracic Soc.

In: Thorax, Vol. 59, 2004, p. 761-768.

Research output: Contribution to journalArticle

@article{477fc2041254423d941bc644addce7f0,
title = "Five year study of etidronate and/or calcium as prevention and treatment for osteoporosis and fractures in patients with asthma receiving long term oral and/or inhaled glucocorticoids",
abstract = "Background: Glucocorticoids are associated with a reduction in bone density and an increased risk of fracture. Concurrent treatment with bisphosphonates reduces bone loss and may prevent fractures. A randomised study was performed to determine whether treatment with cyclical etidronate and/or calcium for 5 years prevents fractures or reverses/reduces bone loss in patients receiving glucocorticoid treatment for asthma.Methods: A multicentre, randomised, parallel group comparison of etidronate alone, calcium alone, etidronate + calcium, and no treatment, with stratification according to level of glucocorticoid exposure was carried out in 39 chest clinics in the UK. Three hundred and forty nine postmenopausal female and male outpatients with asthma aged 50 - 70 years were randomised. The main outcome measures were fractures and changes in bone mineral density (BMD).Results: Overall, 8{\%} of the patients experienced symptomatic fractures and 17.5{\%} developed either a symptomatic fracture and/or a semiquantitative vertebral fracture by the end of 5 years There were no significant differences between the four treatment groups. Comparing etidronate with no etidronate, the rates of new fractures were not significantly different for symptomatic fractures ( OR 1.07 ( 95{\%} CI 0.46 to 2.47)) or for any fractures ( OR 0.82 ( 95{\%} CI 0.45 to 1.47)). For the comparison of calcium with no calcium the corresponding ORs were 1.43 ( 95{\%} CI 0.62 to 3.33) and 0.91 ( 95{\%} CI 0.50 to 1.63). In post hoc analysis the effect of etidronate was greater in women than in men ( interaction p value 0.02) with the fracture incidence roughly halved ( OR 0.39, 95{\%} CI 0.14 to 0.99). Etidronate increased BMD at the lumbar spine by 4.1{\%} ( p = 0.001) while calcium had no significant effect. At the proximal femur the effects of treatment were not significant ( relative increases etidronate 1.6{\%}; calcium 1.1{\%}). The rate of new fractures in patients with fractures at entry (23.7{\%}) was higher than in those without fractures at entry (14.3{\%}): OR 1.87 ( 95{\%} CI 1.06 to 3.07). No association was found between change in BMD and new fractures.Conclusions: In patients receiving glucocorticoids for asthma etidronate significantly increased BMD over 5 years at the lumbar spine but not at the hip and had little if any protective effect against fractures, except possibly in postmenopausal women. The effects of calcium were not significant. Combination treatment had no advantage but increased unwanted effects.",
keywords = "INTERMITTENT CYCLICAL ETIDRONATE, BONE-MINERAL DENSITY, STEROID-INDUCED OSTEOPOROSIS, VERTEBRAL FRACTURE, POSTMENOPAUSAL OSTEOPOROSIS, DOUBLE-BLIND, BECLOMETHASONE DIPROPIONATE, CORTICOSTEROIDS, RISK, THERAPY",
author = "Campbell, {I A} and Douglas, {J G} and Francis, {R M} and Prescott, {R J} and Reid, {D M} and {Res Comm British Thoracic Soc}",
year = "2004",
doi = "10.1136/thx.2003.013839",
language = "English",
volume = "59",
pages = "761--768",
journal = "Thorax",
issn = "0040-6376",
publisher = "BMJ Publishing Group Ltd",

}

TY - JOUR

T1 - Five year study of etidronate and/or calcium as prevention and treatment for osteoporosis and fractures in patients with asthma receiving long term oral and/or inhaled glucocorticoids

AU - Campbell, I A

AU - Douglas, J G

AU - Francis, R M

AU - Prescott, R J

AU - Reid, D M

AU - Res Comm British Thoracic Soc

PY - 2004

Y1 - 2004

N2 - Background: Glucocorticoids are associated with a reduction in bone density and an increased risk of fracture. Concurrent treatment with bisphosphonates reduces bone loss and may prevent fractures. A randomised study was performed to determine whether treatment with cyclical etidronate and/or calcium for 5 years prevents fractures or reverses/reduces bone loss in patients receiving glucocorticoid treatment for asthma.Methods: A multicentre, randomised, parallel group comparison of etidronate alone, calcium alone, etidronate + calcium, and no treatment, with stratification according to level of glucocorticoid exposure was carried out in 39 chest clinics in the UK. Three hundred and forty nine postmenopausal female and male outpatients with asthma aged 50 - 70 years were randomised. The main outcome measures were fractures and changes in bone mineral density (BMD).Results: Overall, 8% of the patients experienced symptomatic fractures and 17.5% developed either a symptomatic fracture and/or a semiquantitative vertebral fracture by the end of 5 years There were no significant differences between the four treatment groups. Comparing etidronate with no etidronate, the rates of new fractures were not significantly different for symptomatic fractures ( OR 1.07 ( 95% CI 0.46 to 2.47)) or for any fractures ( OR 0.82 ( 95% CI 0.45 to 1.47)). For the comparison of calcium with no calcium the corresponding ORs were 1.43 ( 95% CI 0.62 to 3.33) and 0.91 ( 95% CI 0.50 to 1.63). In post hoc analysis the effect of etidronate was greater in women than in men ( interaction p value 0.02) with the fracture incidence roughly halved ( OR 0.39, 95% CI 0.14 to 0.99). Etidronate increased BMD at the lumbar spine by 4.1% ( p = 0.001) while calcium had no significant effect. At the proximal femur the effects of treatment were not significant ( relative increases etidronate 1.6%; calcium 1.1%). The rate of new fractures in patients with fractures at entry (23.7%) was higher than in those without fractures at entry (14.3%): OR 1.87 ( 95% CI 1.06 to 3.07). No association was found between change in BMD and new fractures.Conclusions: In patients receiving glucocorticoids for asthma etidronate significantly increased BMD over 5 years at the lumbar spine but not at the hip and had little if any protective effect against fractures, except possibly in postmenopausal women. The effects of calcium were not significant. Combination treatment had no advantage but increased unwanted effects.

AB - Background: Glucocorticoids are associated with a reduction in bone density and an increased risk of fracture. Concurrent treatment with bisphosphonates reduces bone loss and may prevent fractures. A randomised study was performed to determine whether treatment with cyclical etidronate and/or calcium for 5 years prevents fractures or reverses/reduces bone loss in patients receiving glucocorticoid treatment for asthma.Methods: A multicentre, randomised, parallel group comparison of etidronate alone, calcium alone, etidronate + calcium, and no treatment, with stratification according to level of glucocorticoid exposure was carried out in 39 chest clinics in the UK. Three hundred and forty nine postmenopausal female and male outpatients with asthma aged 50 - 70 years were randomised. The main outcome measures were fractures and changes in bone mineral density (BMD).Results: Overall, 8% of the patients experienced symptomatic fractures and 17.5% developed either a symptomatic fracture and/or a semiquantitative vertebral fracture by the end of 5 years There were no significant differences between the four treatment groups. Comparing etidronate with no etidronate, the rates of new fractures were not significantly different for symptomatic fractures ( OR 1.07 ( 95% CI 0.46 to 2.47)) or for any fractures ( OR 0.82 ( 95% CI 0.45 to 1.47)). For the comparison of calcium with no calcium the corresponding ORs were 1.43 ( 95% CI 0.62 to 3.33) and 0.91 ( 95% CI 0.50 to 1.63). In post hoc analysis the effect of etidronate was greater in women than in men ( interaction p value 0.02) with the fracture incidence roughly halved ( OR 0.39, 95% CI 0.14 to 0.99). Etidronate increased BMD at the lumbar spine by 4.1% ( p = 0.001) while calcium had no significant effect. At the proximal femur the effects of treatment were not significant ( relative increases etidronate 1.6%; calcium 1.1%). The rate of new fractures in patients with fractures at entry (23.7%) was higher than in those without fractures at entry (14.3%): OR 1.87 ( 95% CI 1.06 to 3.07). No association was found between change in BMD and new fractures.Conclusions: In patients receiving glucocorticoids for asthma etidronate significantly increased BMD over 5 years at the lumbar spine but not at the hip and had little if any protective effect against fractures, except possibly in postmenopausal women. The effects of calcium were not significant. Combination treatment had no advantage but increased unwanted effects.

KW - INTERMITTENT CYCLICAL ETIDRONATE

KW - BONE-MINERAL DENSITY

KW - STEROID-INDUCED OSTEOPOROSIS

KW - VERTEBRAL FRACTURE

KW - POSTMENOPAUSAL OSTEOPOROSIS

KW - DOUBLE-BLIND

KW - BECLOMETHASONE DIPROPIONATE

KW - CORTICOSTEROIDS

KW - RISK

KW - THERAPY

U2 - 10.1136/thx.2003.013839

DO - 10.1136/thx.2003.013839

M3 - Article

VL - 59

SP - 761

EP - 768

JO - Thorax

JF - Thorax

SN - 0040-6376

ER -