Efficacy and safety of strontium ranelate in the treatment of osteoporosis in men
Context: Strontium ranelate reduces vertebral and nonvertebral fracture risk in postmenopausal osteoporosis. Objective: The objective of this study was to determine the efficacy and safety of strontium ranelate in osteoporosis in men over 2 years (main analysis after 1 year). Design: This was an int...
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| creator | Kaufman, Jean Audran, M Bianchi, G Braga, V Diaz-Curiel, M Francis, RM Goemaere, Stefan Josse, R Palacios, S Ringe, JD Felsenberg, D Boonen, S |
| description | Context: Strontium ranelate reduces vertebral and nonvertebral fracture risk in postmenopausal osteoporosis.
Objective: The objective of this study was to determine the efficacy and safety of strontium ranelate in osteoporosis in men over 2 years (main analysis after 1 year).
Design: This was an international, unbalanced (2: 1), double-blind, randomized placebo-controlled trial (MALEO [MALE Osteoporosis]).
Setting: This international study included 54 centers in 14 countries.
Participants: Participants were 261 white men with primary osteoporosis.
Intervention: Strontium ranelate at 2 g/d (n = 174) or placebo (n = 87) was administered.
Main Outcome Measures: Lumbar spine (L2-L4), femoral neck, and total hip bone mineral density (BMD), biochemical bone markers, and safety were measured.
Results: Baseline characteristics were similar in both groups in the whole population (age, 72.9 +/- 6.0 years; lumbar spine BMD T-score, -2.7 +/- 1.0; femoral neck BMD T-score, -2.3 +/- 0.7). Men who received strontium ranelate over 2 years had greater increases in lumbar spine BMD than those who received placebo (relative change from baseline to end, 9.7% +/- 7.5% vs 2.0% +/- 5.5%; between-group difference estimate (SE), 7.7% (0.9%); 95% confidence interval, 5.9%-9.5%; P < .001). There were also significant between-group differences in relative changes in femoral neck BMD(P < .001) and total hip BMD (P < .001). At the end of treatment, mean levels of serum cross-linked telopeptides of type I collagen, a marker of bone resorption, were increased in both the strontium ranelate group (10.7% +/- 58.0%; P = .022) and the placebo group (34.9% +/- 65.8%; P < .001). The corresponding mean changes of bone alkaline phosphatase, a marker of bone formation, were 6.4% +/- 28.5% (P = .005) and 1.9% +/- 25.4% (P = .505), respectively. After 2 years, the blood strontium level (129 +/- 66 mu mol/L) was similar to that in trials of postmenopausal osteoporosis. Strontium ranelate was generally well tolerated.
Conclusions: The effects of strontium ranelate on BMD in osteoporotic men were similar to those in postmenopausal osteoporotic women, supporting its use in the treatment of osteoporosis in men. |
| format | Article |
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Objective: The objective of this study was to determine the efficacy and safety of strontium ranelate in osteoporosis in men over 2 years (main analysis after 1 year).
Design: This was an international, unbalanced (2: 1), double-blind, randomized placebo-controlled trial (MALEO [MALE Osteoporosis]).
Setting: This international study included 54 centers in 14 countries.
Participants: Participants were 261 white men with primary osteoporosis.
Intervention: Strontium ranelate at 2 g/d (n = 174) or placebo (n = 87) was administered.
Main Outcome Measures: Lumbar spine (L2-L4), femoral neck, and total hip bone mineral density (BMD), biochemical bone markers, and safety were measured.
Results: Baseline characteristics were similar in both groups in the whole population (age, 72.9 +/- 6.0 years; lumbar spine BMD T-score, -2.7 +/- 1.0; femoral neck BMD T-score, -2.3 +/- 0.7). Men who received strontium ranelate over 2 years had greater increases in lumbar spine BMD than those who received placebo (relative change from baseline to end, 9.7% +/- 7.5% vs 2.0% +/- 5.5%; between-group difference estimate (SE), 7.7% (0.9%); 95% confidence interval, 5.9%-9.5%; P < .001). There were also significant between-group differences in relative changes in femoral neck BMD(P < .001) and total hip BMD (P < .001). At the end of treatment, mean levels of serum cross-linked telopeptides of type I collagen, a marker of bone resorption, were increased in both the strontium ranelate group (10.7% +/- 58.0%; P = .022) and the placebo group (34.9% +/- 65.8%; P < .001). The corresponding mean changes of bone alkaline phosphatase, a marker of bone formation, were 6.4% +/- 28.5% (P = .005) and 1.9% +/- 25.4% (P = .505), respectively. After 2 years, the blood strontium level (129 +/- 66 mu mol/L) was similar to that in trials of postmenopausal osteoporosis. Strontium ranelate was generally well tolerated.
Conclusions: The effects of strontium ranelate on BMD in osteoporotic men were similar to those in postmenopausal osteoporotic women, supporting its use in the treatment of osteoporosis in men.</description><identifier>ISSN: 0021-972X</identifier><language>eng</language><subject>ACID 5 MG ; BONE-MINERAL DENSITY ; DOUBLE-BLIND ; FEMORAL-NECK ; FRACTURE RISK REDUCTION ; HIP FRACTURE ; Medicine and Health Sciences ; NONVERTEBRAL FRACTURES ; POSTMENOPAUSAL OSTEOPOROSIS ; VERTEBRAL FRACTURE ; WOMEN</subject><creationdate>2013</creationdate><rights>No license (in copyright) info:eu-repo/semantics/openAccess</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,315,776,780,4010,27837</link.rule.ids></links><search><creatorcontrib>Kaufman, Jean</creatorcontrib><creatorcontrib>Audran, M</creatorcontrib><creatorcontrib>Bianchi, G</creatorcontrib><creatorcontrib>Braga, V</creatorcontrib><creatorcontrib>Diaz-Curiel, M</creatorcontrib><creatorcontrib>Francis, RM</creatorcontrib><creatorcontrib>Goemaere, Stefan</creatorcontrib><creatorcontrib>Josse, R</creatorcontrib><creatorcontrib>Palacios, S</creatorcontrib><creatorcontrib>Ringe, JD</creatorcontrib><creatorcontrib>Felsenberg, D</creatorcontrib><creatorcontrib>Boonen, S</creatorcontrib><title>Efficacy and safety of strontium ranelate in the treatment of osteoporosis in men</title><description>Context: Strontium ranelate reduces vertebral and nonvertebral fracture risk in postmenopausal osteoporosis.
Objective: The objective of this study was to determine the efficacy and safety of strontium ranelate in osteoporosis in men over 2 years (main analysis after 1 year).
Design: This was an international, unbalanced (2: 1), double-blind, randomized placebo-controlled trial (MALEO [MALE Osteoporosis]).
Setting: This international study included 54 centers in 14 countries.
Participants: Participants were 261 white men with primary osteoporosis.
Intervention: Strontium ranelate at 2 g/d (n = 174) or placebo (n = 87) was administered.
Main Outcome Measures: Lumbar spine (L2-L4), femoral neck, and total hip bone mineral density (BMD), biochemical bone markers, and safety were measured.
Results: Baseline characteristics were similar in both groups in the whole population (age, 72.9 +/- 6.0 years; lumbar spine BMD T-score, -2.7 +/- 1.0; femoral neck BMD T-score, -2.3 +/- 0.7). Men who received strontium ranelate over 2 years had greater increases in lumbar spine BMD than those who received placebo (relative change from baseline to end, 9.7% +/- 7.5% vs 2.0% +/- 5.5%; between-group difference estimate (SE), 7.7% (0.9%); 95% confidence interval, 5.9%-9.5%; P < .001). There were also significant between-group differences in relative changes in femoral neck BMD(P < .001) and total hip BMD (P < .001). At the end of treatment, mean levels of serum cross-linked telopeptides of type I collagen, a marker of bone resorption, were increased in both the strontium ranelate group (10.7% +/- 58.0%; P = .022) and the placebo group (34.9% +/- 65.8%; P < .001). The corresponding mean changes of bone alkaline phosphatase, a marker of bone formation, were 6.4% +/- 28.5% (P = .005) and 1.9% +/- 25.4% (P = .505), respectively. After 2 years, the blood strontium level (129 +/- 66 mu mol/L) was similar to that in trials of postmenopausal osteoporosis. Strontium ranelate was generally well tolerated.
Conclusions: The effects of strontium ranelate on BMD in osteoporotic men were similar to those in postmenopausal osteoporotic women, supporting its use in the treatment of osteoporosis in men.</description><subject>ACID 5 MG</subject><subject>BONE-MINERAL DENSITY</subject><subject>DOUBLE-BLIND</subject><subject>FEMORAL-NECK</subject><subject>FRACTURE RISK REDUCTION</subject><subject>HIP FRACTURE</subject><subject>Medicine and Health Sciences</subject><subject>NONVERTEBRAL FRACTURES</subject><subject>POSTMENOPAUSAL OSTEOPOROSIS</subject><subject>VERTEBRAL FRACTURE</subject><subject>WOMEN</subject><issn>0021-972X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>ADGLB</sourceid><recordid>eNqdi0sKwjAURTNQsH72kA0UkpiijqXiVHDgLLzWlzbSJpK8Ct29LbgCRxfOPWfBMiGUzE8H9VixdUovIaTWxT5jt9JaV0M9cvBPnsAijTxYnigGT27oeQSPHRBy5zm1yCkiUI-eZi0kwvAOMSSXZmHiW7a00CXc_XbD1KW8n695006R6VwVsQYyAZyBWLfug2Zo5qtCo6WSx0Lv_4q-D2FL5A</recordid><startdate>2013</startdate><enddate>2013</enddate><creator>Kaufman, Jean</creator><creator>Audran, M</creator><creator>Bianchi, G</creator><creator>Braga, V</creator><creator>Diaz-Curiel, M</creator><creator>Francis, RM</creator><creator>Goemaere, Stefan</creator><creator>Josse, R</creator><creator>Palacios, S</creator><creator>Ringe, JD</creator><creator>Felsenberg, D</creator><creator>Boonen, S</creator><scope>ADGLB</scope></search><sort><creationdate>2013</creationdate><title>Efficacy and safety of strontium ranelate in the treatment of osteoporosis in men</title><author>Kaufman, Jean ; Audran, M ; Bianchi, G ; Braga, V ; Diaz-Curiel, M ; Francis, RM ; Goemaere, Stefan ; Josse, R ; Palacios, S ; Ringe, JD ; Felsenberg, D ; Boonen, S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-ghent_librecat_oai_archive_ugent_be_41218543</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>ACID 5 MG</topic><topic>BONE-MINERAL DENSITY</topic><topic>DOUBLE-BLIND</topic><topic>FEMORAL-NECK</topic><topic>FRACTURE RISK REDUCTION</topic><topic>HIP FRACTURE</topic><topic>Medicine and Health Sciences</topic><topic>NONVERTEBRAL FRACTURES</topic><topic>POSTMENOPAUSAL OSTEOPOROSIS</topic><topic>VERTEBRAL FRACTURE</topic><topic>WOMEN</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kaufman, Jean</creatorcontrib><creatorcontrib>Audran, M</creatorcontrib><creatorcontrib>Bianchi, G</creatorcontrib><creatorcontrib>Braga, V</creatorcontrib><creatorcontrib>Diaz-Curiel, M</creatorcontrib><creatorcontrib>Francis, RM</creatorcontrib><creatorcontrib>Goemaere, Stefan</creatorcontrib><creatorcontrib>Josse, R</creatorcontrib><creatorcontrib>Palacios, S</creatorcontrib><creatorcontrib>Ringe, JD</creatorcontrib><creatorcontrib>Felsenberg, D</creatorcontrib><creatorcontrib>Boonen, S</creatorcontrib><collection>Ghent University Academic Bibliography</collection></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kaufman, Jean</au><au>Audran, M</au><au>Bianchi, G</au><au>Braga, V</au><au>Diaz-Curiel, M</au><au>Francis, RM</au><au>Goemaere, Stefan</au><au>Josse, R</au><au>Palacios, S</au><au>Ringe, JD</au><au>Felsenberg, D</au><au>Boonen, S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of strontium ranelate in the treatment of osteoporosis in men</atitle><date>2013</date><risdate>2013</risdate><issn>0021-972X</issn><abstract>Context: Strontium ranelate reduces vertebral and nonvertebral fracture risk in postmenopausal osteoporosis.
Objective: The objective of this study was to determine the efficacy and safety of strontium ranelate in osteoporosis in men over 2 years (main analysis after 1 year).
Design: This was an international, unbalanced (2: 1), double-blind, randomized placebo-controlled trial (MALEO [MALE Osteoporosis]).
Setting: This international study included 54 centers in 14 countries.
Participants: Participants were 261 white men with primary osteoporosis.
Intervention: Strontium ranelate at 2 g/d (n = 174) or placebo (n = 87) was administered.
Main Outcome Measures: Lumbar spine (L2-L4), femoral neck, and total hip bone mineral density (BMD), biochemical bone markers, and safety were measured.
Results: Baseline characteristics were similar in both groups in the whole population (age, 72.9 +/- 6.0 years; lumbar spine BMD T-score, -2.7 +/- 1.0; femoral neck BMD T-score, -2.3 +/- 0.7). Men who received strontium ranelate over 2 years had greater increases in lumbar spine BMD than those who received placebo (relative change from baseline to end, 9.7% +/- 7.5% vs 2.0% +/- 5.5%; between-group difference estimate (SE), 7.7% (0.9%); 95% confidence interval, 5.9%-9.5%; P < .001). There were also significant between-group differences in relative changes in femoral neck BMD(P < .001) and total hip BMD (P < .001). At the end of treatment, mean levels of serum cross-linked telopeptides of type I collagen, a marker of bone resorption, were increased in both the strontium ranelate group (10.7% +/- 58.0%; P = .022) and the placebo group (34.9% +/- 65.8%; P < .001). The corresponding mean changes of bone alkaline phosphatase, a marker of bone formation, were 6.4% +/- 28.5% (P = .005) and 1.9% +/- 25.4% (P = .505), respectively. After 2 years, the blood strontium level (129 +/- 66 mu mol/L) was similar to that in trials of postmenopausal osteoporosis. Strontium ranelate was generally well tolerated.
Conclusions: The effects of strontium ranelate on BMD in osteoporotic men were similar to those in postmenopausal osteoporotic women, supporting its use in the treatment of osteoporosis in men.</abstract><oa>free_for_read</oa></addata></record> |
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| source | Journals@Ovid Ovid Autoload; Ghent University Academic Bibliography; Oxford University Press Journals All Titles (1996-Current); EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | ACID 5 MG BONE-MINERAL DENSITY DOUBLE-BLIND FEMORAL-NECK FRACTURE RISK REDUCTION HIP FRACTURE Medicine and Health Sciences NONVERTEBRAL FRACTURES POSTMENOPAUSAL OSTEOPOROSIS VERTEBRAL FRACTURE WOMEN |
| title | Efficacy and safety of strontium ranelate in the treatment of osteoporosis in men |
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