Effects of short-term risedronate on bone resorption and patient satisfaction in postmenopausal osteoporosis patients.
This multicenter, open-label study evaluated the effects of short-term risedronate on bone resorption and patient satisfaction in postmenopausal women with osteoporosis in Brazil. Entry requirements included: osteoporosis of the spine/femoral neck diagnosed by a bone mineral density (BMD) T-score<or=-2.5 or radiographic fragility fracture within the last year and no treatment with osteoporosis medication in the preceding 3 mo. Patients were treated with once weekly risedronate of 35 mg for 12 wk. Patients also received 1000 mg calcium carbonate and 400 IU vitamin D. The main outcome was the effect on bone resorption, as assessed by the quantification of serum C-telopeptide of type I collagen (CTX). Of the 556 women screened, 480 women received >or=1 dose of study drug (intent-to-treat [ITT] population), and 390 completed treatment (81%). After 12 wk, CTX decreased in 94% of patients (from 0.419+/-0.234 to 0.158+/-0.171 microg/L, p<0.0001). Mean CTX reduction was 60.6%. Patient satisfaction was good/excellent in 91.7% of patients. A total of 156 adverse events (AEs) were reported by 113 (23.5%) patients in the ITT population. Digestive symptoms emerged or worsened in 7.1% and 3.5%, respectively. Five patients (1.0%) experienced serious AEs, not considered to be related to risedronate. In conclusion, risedronate significantly reduced serum CTX after 12-wk treatment. Almost all patients reported good/excellent satisfaction.
Fernandes
Cesar E
CE
Gynecology and Obstetric Department, Faculdade de Medicina do ABC, Santo André, São Paulo, Brazil. cesarefernandes@uol.com.br
Zerbini
Cristiano
C
Russo
Luís A
LA
Albernaz
Marco A
MA
Eis
Sergi R
SR
Szejnfeld
Vera L
VL
Pompei
Luciano M
LM
D000368:Aged; D015415:Biomarkers / Q000097:blood; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D016723:Bone Remodeling / Q000187:drug effects*; D001862:Bone Resorption / Q000517:prevention & control*; D024042:Collagen Type I / Q000097:blood; D012968:Etidronic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D017060:Patient Satisfaction; D010455:Peptides / Q000097:blood; D011446:Prospective Studies; D000068296:Risedronic Acid
D015415:Biomarkers; D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D000068296:Risedronic Acid; D012968:Etidronic Acid