TY - JOUR
T1 - Evidence for safety and efficacy of risedronate in men with osteoporosis over 4years of treatment
T2 - Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study
AU - Boonen, Steven
AU - Lorenc, Roman S.
AU - Wenderoth, Dietrich
AU - Stoner, Karen J.
AU - Eusebio, Rachelle
AU - Orwoll, Eric S.
N1 - Funding Information:
SB is the Senior Clinical Investigator for the Fund for Scientific Research (F.W.O.-Vlaanderen), and has received grants for research support from Amgen, Merck, Sanofi, Procter & Gamble Pharmaceuticals, Warner Chilcott, and Servier, and consulting fees from Warner Chilcott and Sanofi. RSL has received grants and consulting fees from Warner Chilcott and Sanofi. DW and KJS are full-time employees of Warner Chilcott. RE is a full-time employee of Procter & Gamble and owns company stock in Procter & Gamble. ESO has received research support and consulting fees from Merck, Lilly, Amgen, and Wright Medical Technologies.
PY - 2012/9
Y1 - 2012/9
N2 - A 2-year, randomized, double-blind, placebo-controlled study in men with osteoporosis demonstrated that treatment with risedronate 35. mg once a week significantly decreased bone turnover markers (BTMs) and increased bone mineral density (BMD). This study was extended to include a 2-year, open-label extension to continue to assess the safety and efficacy of risedronate in men with osteoporosis. In the open-label extension, all patients received risedronate 35. mg once a week, and 1000. mg elemental calcium and 400 to 500. IU vitamin D daily for up to 2. years. The safety of risedronate was evaluated based on adverse events, laboratory data, vital signs, and physical examination results. BMD, BTMs, and the incidence of new vertebral fractures were also assessed. A total of 218 (of 284) patients enrolled in the open-label extension. Risedronate continued to produce significant increases in lumbar spine BMD from baseline (7.87%) in the group of patients who took it for 4. years. Risedronate produced significant increases in lumbar spine BMD from baseline (6.27%) in the former placebo group who took it for 2. years during the open-label extension. Few new vertebral and clinical fractures occurred during the study. There were no significant differences in BTMs between the two groups at months 36 and 48. Incidences of any upper GI adverse events during the extension were low and similar in the two groups; however, the percent of moderate to severe events were higher (8% versus 2%) in the group that received placebo prior to the extension. Safety results continued to show that risedronate was well-tolerated in men with osteoporosis. Patients who received risedronate 35. mg once a week for 2. years in the open-label extension study showed similar safety and efficacy results compared with those who received risedronate treatment in the first 2 double-blind years of the study. Patients who received risedronate for 4. years in total showed similar safety and efficacy to that observed in women with postmenopausal osteoporosis treated with risedronate for 4. years. (ClinicalTrials.gov Identifier number: NCT00619957).
AB - A 2-year, randomized, double-blind, placebo-controlled study in men with osteoporosis demonstrated that treatment with risedronate 35. mg once a week significantly decreased bone turnover markers (BTMs) and increased bone mineral density (BMD). This study was extended to include a 2-year, open-label extension to continue to assess the safety and efficacy of risedronate in men with osteoporosis. In the open-label extension, all patients received risedronate 35. mg once a week, and 1000. mg elemental calcium and 400 to 500. IU vitamin D daily for up to 2. years. The safety of risedronate was evaluated based on adverse events, laboratory data, vital signs, and physical examination results. BMD, BTMs, and the incidence of new vertebral fractures were also assessed. A total of 218 (of 284) patients enrolled in the open-label extension. Risedronate continued to produce significant increases in lumbar spine BMD from baseline (7.87%) in the group of patients who took it for 4. years. Risedronate produced significant increases in lumbar spine BMD from baseline (6.27%) in the former placebo group who took it for 2. years during the open-label extension. Few new vertebral and clinical fractures occurred during the study. There were no significant differences in BTMs between the two groups at months 36 and 48. Incidences of any upper GI adverse events during the extension were low and similar in the two groups; however, the percent of moderate to severe events were higher (8% versus 2%) in the group that received placebo prior to the extension. Safety results continued to show that risedronate was well-tolerated in men with osteoporosis. Patients who received risedronate 35. mg once a week for 2. years in the open-label extension study showed similar safety and efficacy results compared with those who received risedronate treatment in the first 2 double-blind years of the study. Patients who received risedronate for 4. years in total showed similar safety and efficacy to that observed in women with postmenopausal osteoporosis treated with risedronate for 4. years. (ClinicalTrials.gov Identifier number: NCT00619957).
KW - Bisphosphonates
KW - Bone mineral density
KW - Bone turnover markers
KW - Male osteoporosis
KW - Risedronate
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U2 - 10.1016/j.bone.2012.06.016
DO - 10.1016/j.bone.2012.06.016
M3 - Article
C2 - 22750403
AN - SCOPUS:84863820744
SN - 8756-3282
VL - 51
SP - 383
EP - 388
JO - Bone
JF - Bone
IS - 3
ER -