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Five years of treatment with risedronate and its effects on bone safety in women with postmenopausal osteoporosis.
Calcif Tissue Int. 2004 Dec; 75(6):469-76.CT

Abstract

We have recently reported that risedronate preserves normal bone formation and decreases bone remodeling in women with postmenopausal osteoporosis after 3 years of treatment. We report now the results of a 2-year extension study. The primary objective of this study was to determine the effect of 5 years of risedronate treatment (5 mg daily) on bone quality and bone remodeling based on paired transiliac bone biopsies. There were additional measurements that included bone turnover markers and bone mineral density (BMD). Histologic evaluation of biopsy sections (placebo, n = 21; risedronate, n = 27) yielded no pathologic findings after 5 years in either treatment group. Histomorphometric assessment of paired biopsy specimens after 5 years (placebo, n =12; risedronate, n = 13) found no statistically significant differences between treatment groups in structural or resorption parameters. There was a significant reduction in osteoid (-27%) and mineralizing surfaces (-49%) from baseline values in the risedronate group that were also significantly different from placebo at 5 years. Similarly, activation frequency decreased significantly (-77%) in the risedronate group, although it was not significantly different from placebo at 5 years (0.09 vs. 0.21, respectively). Double tetracycline labels were identified in all biopsy specimens indicating continuous bone turnover. After 5 years of risedronate treatment, serum bone-specific alkaline phosphatase (bone ALP) and N-telopeptide (NTX) decreased significantly from baseline by 33.3% and 47.5%, respectively. In the placebo group, bone ALP decreased by 3.9% (P = NS), whereas NTX decreased by 27.0% (P < 0.005). Lumbar spine BMD increased significantly in the risedronate group (9.2%), whereas no significant change was seen in the placebo group (-0.26%). Risedronate was overall well tolerated; during the 2-year study extension nonvertebral fractures occurred in 7 patients in placebo and 2 patients in risedronate groups. The findings from this study are consistent with the antiremodeling effect of risedronate and support long-term bone safety and antifracture efficacy of risedronate treatment.

Authors+Show Affiliations

Centre de Recherche du CHUM Hôspital, Saint-Luc Montreal, Quebec, Canada.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15478000

Citation

Ste-Marie, L-G, et al. "Five Years of Treatment With Risedronate and Its Effects On Bone Safety in Women With Postmenopausal Osteoporosis." Calcified Tissue International, vol. 75, no. 6, 2004, pp. 469-76.
Ste-Marie LG, Sod E, Johnson T, et al. Five years of treatment with risedronate and its effects on bone safety in women with postmenopausal osteoporosis. Calcif Tissue Int. 2004;75(6):469-76.
Ste-Marie, L. G., Sod, E., Johnson, T., & Chines, A. (2004). Five years of treatment with risedronate and its effects on bone safety in women with postmenopausal osteoporosis. Calcified Tissue International, 75(6), 469-76.
Ste-Marie LG, et al. Five Years of Treatment With Risedronate and Its Effects On Bone Safety in Women With Postmenopausal Osteoporosis. Calcif Tissue Int. 2004;75(6):469-76. PubMed PMID: 15478000.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Five years of treatment with risedronate and its effects on bone safety in women with postmenopausal osteoporosis. AU - Ste-Marie,L-G, AU - Sod,E, AU - Johnson,T, AU - Chines,A, Y1 - 2004/10/14/ PY - 2004/03/01/received PY - 2004/07/14/accepted PY - 2004/10/13/pubmed PY - 2005/4/22/medline PY - 2004/10/13/entrez SP - 469 EP - 76 JF - Calcified tissue international JO - Calcif Tissue Int VL - 75 IS - 6 N2 - We have recently reported that risedronate preserves normal bone formation and decreases bone remodeling in women with postmenopausal osteoporosis after 3 years of treatment. We report now the results of a 2-year extension study. The primary objective of this study was to determine the effect of 5 years of risedronate treatment (5 mg daily) on bone quality and bone remodeling based on paired transiliac bone biopsies. There were additional measurements that included bone turnover markers and bone mineral density (BMD). Histologic evaluation of biopsy sections (placebo, n = 21; risedronate, n = 27) yielded no pathologic findings after 5 years in either treatment group. Histomorphometric assessment of paired biopsy specimens after 5 years (placebo, n =12; risedronate, n = 13) found no statistically significant differences between treatment groups in structural or resorption parameters. There was a significant reduction in osteoid (-27%) and mineralizing surfaces (-49%) from baseline values in the risedronate group that were also significantly different from placebo at 5 years. Similarly, activation frequency decreased significantly (-77%) in the risedronate group, although it was not significantly different from placebo at 5 years (0.09 vs. 0.21, respectively). Double tetracycline labels were identified in all biopsy specimens indicating continuous bone turnover. After 5 years of risedronate treatment, serum bone-specific alkaline phosphatase (bone ALP) and N-telopeptide (NTX) decreased significantly from baseline by 33.3% and 47.5%, respectively. In the placebo group, bone ALP decreased by 3.9% (P = NS), whereas NTX decreased by 27.0% (P < 0.005). Lumbar spine BMD increased significantly in the risedronate group (9.2%), whereas no significant change was seen in the placebo group (-0.26%). Risedronate was overall well tolerated; during the 2-year study extension nonvertebral fractures occurred in 7 patients in placebo and 2 patients in risedronate groups. The findings from this study are consistent with the antiremodeling effect of risedronate and support long-term bone safety and antifracture efficacy of risedronate treatment. SN - 0171-967X UR - https://www.unboundmedicine.com/medline/citation/15478000/Five_years_of_treatment_with_risedronate_and_its_effects_on_bone_safety_in_women_with_postmenopausal_osteoporosis_ L2 - https://dx.doi.org/10.1007/s00223-004-0039-7 DB - PRIME DP - Unbound Medicine ER -