Effectiveness of risedronate in osteoporotic postmenopausal women with inflammatory bowel disease: a prospective, parallel, open-label, two-year extension study.
OBJECTIVE
To evaluate long-term efficacy of risedronate in osteoporotic postmenopausal patients with inflammatory bowel disease (IBD).


METHODS
A prospective, parallel, open-label, 2-year extension study of a randomized, double-blind, 1-year clinical trial. Eighty-one osteoporotic postmenopausal women with IBD were treated with risedronate (n = 40) or placebo (n = 41). Bone mineral density (BMD), biochemical bone turnover markers, and vertebral and nonvertebral fractures were assessed throughout the study. Data were analyzed using the intent-to-treat principle.


RESULTS
Significant (P < 0.05) differences were observed between risedronate and placebo groups at 1-, 2-, and 3-year follow-up visits in bone turnover markers and in lumbar spine, trochanter, and femoral neck BMD. In participants treated with risedronate, the percentage of changes from baseline in bone turnover markers and in lumbar spine, trochanter, and femoral neck BMD were significantly (P < 0.05) higher at 2- and 3-year follow-up in comparison with baseline and 1-year follow-up, with a significant (P < 0.05) difference between the 2- and 3-year follow-up visits. At the end of the study, the cumulative risk of vertebral and nonvertebral fractures was significantly (P < 0.05) lower in the risedronate group than in the placebo group. The relative risk for new vertebral fractures was 0.456 (95% CI: 0.134-1.559, P = 0.211) and 0.296 (95% CI: 0.121-0.721, P = 0.007) and was 0.209 (95% CI: 0.023-1.867, P = 0.161) and 0.137 (95% CI: 0.030-0.620, P = 0.010), respectively, for new nonvertebral fractures after 2 and 3 years of risedronate treatment.


CONCLUSIONS
In postmenopausal osteoporotic women with IBD, long-term treatment with risedronate is effective in increasing BMD and reducing vertebral and nonvertebral fracture risk.
Palomba
Stefano
S
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro, Catanzaro, Italy. stefanopalomba@tin.it
Manguso
Francesco
F
Orio
Francesco
F
Russo
Tiziana
T
Oppedisano
Rosamaria
R
Sacchinelli
Angela
A
Falbo
Angela
A
Tolino
Achille
A
Zullo
Fulvio
F
Mastrantonio
Pasquale
P
D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D016723:Bone Remodeling / Q000187:drug effects; D004311:Double-Blind Method; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005598:Fractures, Spontaneous / Q000209:etiology; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000150:complications*; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy*; D000068296:Risedronic Acid; D016103:Spinal Fractures / Q000209:etiology
D050071:Bone Density Conservation Agents; D000068296:Risedronic Acid; D012968:Etidronic Acid