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Effectiveness of risedronate in osteoporotic postmenopausal women with inflammatory bowel disease: a prospective, parallel, open-label, two-year extension study.
Menopause. 2008 Jul-Aug; 15(4 Pt 1):730-6.M

Abstract

OBJECTIVE

To evaluate long-term efficacy of risedronate in osteoporotic postmenopausal patients with inflammatory bowel disease (IBD).

DESIGN

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.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro, Catanzaro, Italy. stefanopalomba@tin.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

18698280

Citation

Palomba, Stefano, et al. "Effectiveness of Risedronate in Osteoporotic Postmenopausal Women With Inflammatory Bowel Disease: a Prospective, Parallel, Open-label, Two-year Extension Study." Menopause (New York, N.Y.), vol. 15, no. 4 Pt 1, 2008, pp. 730-6.
Palomba S, Manguso F, Orio F, et al. Effectiveness of risedronate in osteoporotic postmenopausal women with inflammatory bowel disease: a prospective, parallel, open-label, two-year extension study. Menopause. 2008;15(4 Pt 1):730-6.
Palomba, S., Manguso, F., Orio, F., Russo, T., Oppedisano, R., Sacchinelli, A., Falbo, A., Tolino, A., Zullo, F., & Mastrantonio, P. (2008). Effectiveness of risedronate in osteoporotic postmenopausal women with inflammatory bowel disease: a prospective, parallel, open-label, two-year extension study. Menopause (New York, N.Y.), 15(4 Pt 1), 730-6. https://doi.org/10.1097/gme.0b013e318159f190
Palomba S, et al. Effectiveness of Risedronate in Osteoporotic Postmenopausal Women With Inflammatory Bowel Disease: a Prospective, Parallel, Open-label, Two-year Extension Study. Menopause. 2008 Jul-Aug;15(4 Pt 1):730-6. PubMed PMID: 18698280.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness of risedronate in osteoporotic postmenopausal women with inflammatory bowel disease: a prospective, parallel, open-label, two-year extension study. AU - Palomba,Stefano, AU - Manguso,Francesco, AU - Orio,Francesco,Jr AU - Russo,Tiziana, AU - Oppedisano,Rosamaria, AU - Sacchinelli,Angela, AU - Falbo,Angela, AU - Tolino,Achille, AU - Zullo,Fulvio, AU - Mastrantonio,Pasquale, PY - 2008/8/14/pubmed PY - 2008/9/16/medline PY - 2008/8/14/entrez SP - 730 EP - 6 JF - Menopause (New York, N.Y.) JO - Menopause VL - 15 IS - 4 Pt 1 N2 - OBJECTIVE: To evaluate long-term efficacy of risedronate in osteoporotic postmenopausal patients with inflammatory bowel disease (IBD). DESIGN: 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. SN - 1072-3714 UR - https://www.unboundmedicine.com/medline/citation/18698280/Effectiveness_of_risedronate_in_osteoporotic_postmenopausal_women_with_inflammatory_bowel_disease:_a_prospective_parallel_open_label_two_year_extension_study_ L2 - https://doi.org/10.1097/gme.0b013e318159f190 DB - PRIME DP - Unbound Medicine ER -