Compared clinical efficacy and bone metabolic effects of low-dose deflazacort and methyl prednisolone in male inflammatory arthropathies: A 12-month open randomized pilot study

G. Saviola, L. Abdi. Ali, Eddin S. Shams, A. Coppini, F. Cavalieri, L. Campostrini, S. Sacco, M. Bucci, G. Cirino, M. Rossini

Research output: Contribution to journalArticle

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Abstract

Objective. To evaluate: (i) a correct equivalence ratio of clinical efficacy between low-dose deflazacort (DFZ) and methyl prednisolone (MP); and (ii) bone metabolic effects of low-dose DFZ and MP in the treatment of male RA and PsA. Methods. A total of 21 male patients with active RA or PsA, naive to steroid treatment were chosen for the study. Group I: 10 patients treated for 6 months with DFZ 7.5 mg, calcium, cholecalciferol and a DMARD; for the following 6 months with MP 4 mg, calcium, cholecalciferol and a DMARD. Group II: 11 patients treated for 6 months with MP 4 mg, calcium, cholecalciferol and a DMARD; for the following 6 months with DFZ 7.5 mg, calcium, cholecalciferol and a DMARD. At day 0, 90, 180, 240 and 360 evaluation of ACR improvement criteria; a blood sample for total and bone-specific ALP, calcium, phosphorus, PTH, SHBG, estradiol, ACTH, osteocalcin, LH, OPG; a sample of urine for calcium, phosphorus, creatinine and DPD. Results. 13/21 patients (6/10 Group I; 7/11 Group II) reached ACR 20 at 6 months; 14/21 (7/10 Group I, 7/10 Group II) at 12 months. Only at the third month we observed in Group II vs Group I a reduction of OPG (24% vs 6%, P=n.s.); ALP (P lt; 0.001) and osteocalcin (P=0.006) decreased in both groups from the third month; DPD decreased in both groups only from the sixth month (P=0.002). Conclusions. The correct equivalence ratio of DFZ to MP is 1.875:1, and of DFZ to prednisolone 1.5:1. We found a relative prevalence of bone resorption compared to bone formation in the first 6 months of treatment. The trend of OPG requires further investigation.

Original languageEnglish
Pages (from-to)994-998
Number of pages5
JournalRheumatology
Volume46
Issue number6
DOIs
Publication statusPublished - Jun 2007

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compound A 12
Joint Diseases
Prednisolone
Antirheumatic Agents
Cholecalciferol
Calcium
Bone and Bones
Osteocalcin
Phosphorus
Bone Resorption
Osteogenesis
Adrenocorticotropic Hormone
deflazacort
Estradiol
Creatinine
Therapeutics
Steroids
Urine

Keywords

  • Deflazacort
  • Glucocorticoid-induced osteoporosis
  • Methylprednisolone
  • Osteoprotegerin
  • Psoriatic arthritis
  • Rheumatoid arthritis

ASJC Scopus subject areas

  • Neuroscience(all)
  • Rheumatology

Cite this

Compared clinical efficacy and bone metabolic effects of low-dose deflazacort and methyl prednisolone in male inflammatory arthropathies : A 12-month open randomized pilot study. / Saviola, G.; Abdi. Ali, L.; Shams, Eddin S.; Coppini, A.; Cavalieri, F.; Campostrini, L.; Sacco, S.; Bucci, M.; Cirino, G.; Rossini, M.

In: Rheumatology, Vol. 46, No. 6, 06.2007, p. 994-998.

Research output: Contribution to journalArticle

Saviola, G. ; Abdi. Ali, L. ; Shams, Eddin S. ; Coppini, A. ; Cavalieri, F. ; Campostrini, L. ; Sacco, S. ; Bucci, M. ; Cirino, G. ; Rossini, M. / Compared clinical efficacy and bone metabolic effects of low-dose deflazacort and methyl prednisolone in male inflammatory arthropathies : A 12-month open randomized pilot study. In: Rheumatology. 2007 ; Vol. 46, No. 6. pp. 994-998.
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abstract = "Objective. To evaluate: (i) a correct equivalence ratio of clinical efficacy between low-dose deflazacort (DFZ) and methyl prednisolone (MP); and (ii) bone metabolic effects of low-dose DFZ and MP in the treatment of male RA and PsA. Methods. A total of 21 male patients with active RA or PsA, naive to steroid treatment were chosen for the study. Group I: 10 patients treated for 6 months with DFZ 7.5 mg, calcium, cholecalciferol and a DMARD; for the following 6 months with MP 4 mg, calcium, cholecalciferol and a DMARD. Group II: 11 patients treated for 6 months with MP 4 mg, calcium, cholecalciferol and a DMARD; for the following 6 months with DFZ 7.5 mg, calcium, cholecalciferol and a DMARD. At day 0, 90, 180, 240 and 360 evaluation of ACR improvement criteria; a blood sample for total and bone-specific ALP, calcium, phosphorus, PTH, SHBG, estradiol, ACTH, osteocalcin, LH, OPG; a sample of urine for calcium, phosphorus, creatinine and DPD. Results. 13/21 patients (6/10 Group I; 7/11 Group II) reached ACR 20 at 6 months; 14/21 (7/10 Group I, 7/10 Group II) at 12 months. Only at the third month we observed in Group II vs Group I a reduction of OPG (24{\%} vs 6{\%}, P=n.s.); ALP (P lt; 0.001) and osteocalcin (P=0.006) decreased in both groups from the third month; DPD decreased in both groups only from the sixth month (P=0.002). Conclusions. The correct equivalence ratio of DFZ to MP is 1.875:1, and of DFZ to prednisolone 1.5:1. We found a relative prevalence of bone resorption compared to bone formation in the first 6 months of treatment. The trend of OPG requires further investigation.",
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author = "G. Saviola and {Abdi. Ali}, L. and Shams, {Eddin S.} and A. Coppini and F. Cavalieri and L. Campostrini and S. Sacco and M. Bucci and G. Cirino and M. Rossini",
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T1 - Compared clinical efficacy and bone metabolic effects of low-dose deflazacort and methyl prednisolone in male inflammatory arthropathies

T2 - A 12-month open randomized pilot study

AU - Saviola, G.

AU - Abdi. Ali, L.

AU - Shams, Eddin S.

AU - Coppini, A.

AU - Cavalieri, F.

AU - Campostrini, L.

AU - Sacco, S.

AU - Bucci, M.

AU - Cirino, G.

AU - Rossini, M.

PY - 2007/6

Y1 - 2007/6

N2 - Objective. To evaluate: (i) a correct equivalence ratio of clinical efficacy between low-dose deflazacort (DFZ) and methyl prednisolone (MP); and (ii) bone metabolic effects of low-dose DFZ and MP in the treatment of male RA and PsA. Methods. A total of 21 male patients with active RA or PsA, naive to steroid treatment were chosen for the study. Group I: 10 patients treated for 6 months with DFZ 7.5 mg, calcium, cholecalciferol and a DMARD; for the following 6 months with MP 4 mg, calcium, cholecalciferol and a DMARD. Group II: 11 patients treated for 6 months with MP 4 mg, calcium, cholecalciferol and a DMARD; for the following 6 months with DFZ 7.5 mg, calcium, cholecalciferol and a DMARD. At day 0, 90, 180, 240 and 360 evaluation of ACR improvement criteria; a blood sample for total and bone-specific ALP, calcium, phosphorus, PTH, SHBG, estradiol, ACTH, osteocalcin, LH, OPG; a sample of urine for calcium, phosphorus, creatinine and DPD. Results. 13/21 patients (6/10 Group I; 7/11 Group II) reached ACR 20 at 6 months; 14/21 (7/10 Group I, 7/10 Group II) at 12 months. Only at the third month we observed in Group II vs Group I a reduction of OPG (24% vs 6%, P=n.s.); ALP (P lt; 0.001) and osteocalcin (P=0.006) decreased in both groups from the third month; DPD decreased in both groups only from the sixth month (P=0.002). Conclusions. The correct equivalence ratio of DFZ to MP is 1.875:1, and of DFZ to prednisolone 1.5:1. We found a relative prevalence of bone resorption compared to bone formation in the first 6 months of treatment. The trend of OPG requires further investigation.

AB - Objective. To evaluate: (i) a correct equivalence ratio of clinical efficacy between low-dose deflazacort (DFZ) and methyl prednisolone (MP); and (ii) bone metabolic effects of low-dose DFZ and MP in the treatment of male RA and PsA. Methods. A total of 21 male patients with active RA or PsA, naive to steroid treatment were chosen for the study. Group I: 10 patients treated for 6 months with DFZ 7.5 mg, calcium, cholecalciferol and a DMARD; for the following 6 months with MP 4 mg, calcium, cholecalciferol and a DMARD. Group II: 11 patients treated for 6 months with MP 4 mg, calcium, cholecalciferol and a DMARD; for the following 6 months with DFZ 7.5 mg, calcium, cholecalciferol and a DMARD. At day 0, 90, 180, 240 and 360 evaluation of ACR improvement criteria; a blood sample for total and bone-specific ALP, calcium, phosphorus, PTH, SHBG, estradiol, ACTH, osteocalcin, LH, OPG; a sample of urine for calcium, phosphorus, creatinine and DPD. Results. 13/21 patients (6/10 Group I; 7/11 Group II) reached ACR 20 at 6 months; 14/21 (7/10 Group I, 7/10 Group II) at 12 months. Only at the third month we observed in Group II vs Group I a reduction of OPG (24% vs 6%, P=n.s.); ALP (P lt; 0.001) and osteocalcin (P=0.006) decreased in both groups from the third month; DPD decreased in both groups only from the sixth month (P=0.002). Conclusions. The correct equivalence ratio of DFZ to MP is 1.875:1, and of DFZ to prednisolone 1.5:1. We found a relative prevalence of bone resorption compared to bone formation in the first 6 months of treatment. The trend of OPG requires further investigation.

KW - Deflazacort

KW - Glucocorticoid-induced osteoporosis

KW - Methylprednisolone

KW - Osteoprotegerin

KW - Psoriatic arthritis

KW - Rheumatoid arthritis

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