Sustained efficacy of risedronate in men with primary and secondary osteoporosis: results of a 2-year study |
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Authors: | Johann D Ringe Parvis Farahmand Herbert Faber Alfred Dorst |
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Institution: | (1) Medizinische Klink IV, Klinikum Leverkusen, Teaching Hospital of the University of Cologne, 51375 Leverkusen, Germany |
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Abstract: | The aim of this study was to assess the effect of treatment with risedronate 5 mg daily relative to control in men with primary
or secondary osteoporosis over 2 years. Osteoporosis is a common condition in men that can have serious clinical consequences.
In an earlier interim report, we found that 1 year of risedronate therapy resulted in significant increases in bone mineral
density (BMD) and a significant reduction in vertebral fractures compared to control in men with osteoporosis. We conducted
an open-label, prospective, match-control trial on men with primary or secondary osteoporosis in a single center, outpatient
setting. Men with primary or secondary osteoporosis, as defined by a baseline lumbar spine BMD T-score ≤ −2.5 and a baseline femoral neck BMD T-score ≤ 2.0, were eligible for this study. Patients who had been treated with bisphosphonates or fluoride within the last
12 months were excluded. A total of 316 men were randomized to risedronate (n = 158) or control (n = 158). Patients were stratified by the presence of prevalent vertebral fractures at baseline and case by case allocated
to either daily treatment with risedronate 5 mg daily plus calcium (1,000 mg) and vitamin D (800 IU) or to a control group
(daily alfacalcidol (1 μg) plus calcium (500 mg) for those with prevalent vertebral fractures; daily vitamin D (800 IU) plus
calcium (1,200 mg) for those without previous vertebral fractures). Primary study end points were identified prior to study
initiation as the incidence of new vertebral fractures and changes in BMD at the lumbar spine, femoral neck, and total hip.
Other end points included incidence of nonvertebral fractures and change in body height and back pain. Compared to control,
the incidence of new vertebral fractures was significantly reduced in the risedronate 5 mg daily group at 2 years 14/152
(9.2%) for risedronate vs. 35/148 (23.6%) for control (61% risk reduction; P = 0.0026)]. Treatment with risedronate 5 mg daily also resulted in significant improvements in BMD at 2 years at all three
skeletal sites (lumbar spine, 6.5 vs. 2.2%; femoral neck, 3.2 vs. 0.6%; total hip, 4.4 vs. 0.4% (P < 0.001 for all treatment comparisons). Significant reductions in the incidence of nonvertebral fractures (11.8 vs. 22.3%;
P = 0.032), average loss in height, and back pain were also observed in risedronate-treated patients relative to control. In
this 2-year study, daily 5 mg risedronate significantly reduced the risk of vertebral and nonvertebral fractures, improved
BMD, decreased height loss, and reduced back pain in men with osteoporosis. Efficacy was sustained over 2 years; a consistent
60–61% risk reduction in vertebral fractures was observed at 1 and 2 years, respectively. These data demonstrate that daily
risedronate is effective long-term therapy for men with primary or secondary osteoporosis. |
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Keywords: | Risedronate Male Osteoporosis Bisphosphonates Vertebral fracture Non-vertebral fracture |
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