Effectiveness of anti-osteoporotic treatment after successful parathyroidectomy for primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial

Purpose After successful surgery for primary hyperparathyroidism, bone mineral density (BMD) does not improve equally in all patients. As no trial has so far aimed to influence normalization of BMD, it was the goal of this investigation to determine whether pharmacological treatment is effective in...

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Veröffentlicht in:Langenbeck's archives of surgery 2019-09, Vol.404 (6), p.681-691
Hauptverfasser: Niederle, Martin B., Foeger-Samwald, Ursula, Riss, Philipp, Selberherr, Andreas, Scheuba, Christian, Pietschmann, Peter, Niederle, Bruno, Kerschan-Schindl, Katharina
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container_start_page 681
container_title Langenbeck's archives of surgery
container_volume 404
creator Niederle, Martin B.
Foeger-Samwald, Ursula
Riss, Philipp
Selberherr, Andreas
Scheuba, Christian
Pietschmann, Peter
Niederle, Bruno
Kerschan-Schindl, Katharina
description Purpose After successful surgery for primary hyperparathyroidism, bone mineral density (BMD) does not improve equally in all patients. As no trial has so far aimed to influence normalization of BMD, it was the goal of this investigation to determine whether pharmacological treatment is effective in improving regain of BMD after successful parathyroidectomy in patients with preoperatively diagnosed osteoporosis or osteopenia and to evaluate when treatment may be indicated. Methods In this randomized, placebo-controlled, double-blind trial, 52 patients were treated with strontium ranelate 2 g daily + 1000 mg calcium + 800 IU vitamin D (strontium group; SG) or with 1000 mg calcium + 800 IU vitamin D alone (placebo group; PG) for 1 year. The main outcome measures were BMD (lumbar spine, femoral neck, radius) and bone turnover markers. Results The baseline characteristics were similar in both groups. Absolute BMD (1.007 ± 0.197 vs. 0.897 ± 0.137 g/cm 2 ; p  = 0.024) and both relative (9.94 vs. 3.94%; p  
doi_str_mv 10.1007/s00423-019-01815-9
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As no trial has so far aimed to influence normalization of BMD, it was the goal of this investigation to determine whether pharmacological treatment is effective in improving regain of BMD after successful parathyroidectomy in patients with preoperatively diagnosed osteoporosis or osteopenia and to evaluate when treatment may be indicated. Methods In this randomized, placebo-controlled, double-blind trial, 52 patients were treated with strontium ranelate 2 g daily + 1000 mg calcium + 800 IU vitamin D (strontium group; SG) or with 1000 mg calcium + 800 IU vitamin D alone (placebo group; PG) for 1 year. The main outcome measures were BMD (lumbar spine, femoral neck, radius) and bone turnover markers. Results The baseline characteristics were similar in both groups. Absolute BMD (1.007 ± 0.197 vs. 0.897 ± 0.137 g/cm 2 ; p  = 0.024) and both relative (9.94 vs. 3.94%; p  &lt; 0.001) and absolute (0.09 ± 0.06 vs. 0.03 ± 0.04 g/cm 2 ; p  &lt; 0.001) changes in lumbar-spine BMD were significantly higher in the SG than in the PG. Compared to baseline, BMD significantly increased in both groups at the lumbar spine ( p  &lt; 0.001 and p  = 0.001, respectively) and femoral neck (both p  &lt; 0.001), whereas radius BMD only changed significantly in the SG. However, the proportion of patients with osteoporosis/osteopenia significantly declined only at the lumbar spine in the SG (from 69.0 to 37.9%; p  = 0.034), whereas no decrease was found in the PG. No severe adverse events occurred. Conclusions Postoperative anti-osteoporotic treatment can positively influence regain of BMD mainly in the lumbar spine and should be considered. Without treatment, most patients and especially those with low preoperative markers of bone turnover remained osteoporotic/osteopenic 1 year after surgery.</description><identifier>ISSN: 1435-2443</identifier><identifier>ISSN: 1435-2451</identifier><identifier>EISSN: 1435-2451</identifier><identifier>DOI: 10.1007/s00423-019-01815-9</identifier><identifier>PMID: 31451913</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Abdominal Surgery ; Bone Density - drug effects ; Bone Diseases, Metabolic - drug therapy ; Bone Diseases, Metabolic - etiology ; Bone Remodeling ; Calcium - therapeutic use ; Cardiac Surgery ; Controlled Clinical Trial ; Double-Blind Method ; Female ; General Surgery ; Humans ; Hyperparathyroidism, Primary - complications ; Hyperparathyroidism, Primary - surgery ; Male ; Medicine ; Medicine &amp; Public Health ; Middle Aged ; Osteoporosis - drug therapy ; Osteoporosis - etiology ; Parathyroidectomy ; Thiophenes - therapeutic use ; Thoracic Surgery ; Traumatic Surgery ; Vascular Surgery ; Vitamin D - therapeutic use</subject><ispartof>Langenbeck's archives of surgery, 2019-09, Vol.404 (6), p.681-691</ispartof><rights>The Author(s) 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c446t-7ffdc754f1d463f486fb5cd48bb93c40c452a443cef8591f3bb60fd078ec2db3</citedby><cites>FETCH-LOGICAL-c446t-7ffdc754f1d463f486fb5cd48bb93c40c452a443cef8591f3bb60fd078ec2db3</cites><orcidid>0000-0003-0450-6132</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00423-019-01815-9$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00423-019-01815-9$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31451913$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Niederle, Martin B.</creatorcontrib><creatorcontrib>Foeger-Samwald, Ursula</creatorcontrib><creatorcontrib>Riss, Philipp</creatorcontrib><creatorcontrib>Selberherr, Andreas</creatorcontrib><creatorcontrib>Scheuba, Christian</creatorcontrib><creatorcontrib>Pietschmann, Peter</creatorcontrib><creatorcontrib>Niederle, Bruno</creatorcontrib><creatorcontrib>Kerschan-Schindl, Katharina</creatorcontrib><title>Effectiveness of anti-osteoporotic treatment after successful parathyroidectomy for primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial</title><title>Langenbeck's archives of surgery</title><addtitle>Langenbecks Arch Surg</addtitle><addtitle>Langenbecks Arch Surg</addtitle><description>Purpose After successful surgery for primary hyperparathyroidism, bone mineral density (BMD) does not improve equally in all patients. As no trial has so far aimed to influence normalization of BMD, it was the goal of this investigation to determine whether pharmacological treatment is effective in improving regain of BMD after successful parathyroidectomy in patients with preoperatively diagnosed osteoporosis or osteopenia and to evaluate when treatment may be indicated. Methods In this randomized, placebo-controlled, double-blind trial, 52 patients were treated with strontium ranelate 2 g daily + 1000 mg calcium + 800 IU vitamin D (strontium group; SG) or with 1000 mg calcium + 800 IU vitamin D alone (placebo group; PG) for 1 year. The main outcome measures were BMD (lumbar spine, femoral neck, radius) and bone turnover markers. Results The baseline characteristics were similar in both groups. Absolute BMD (1.007 ± 0.197 vs. 0.897 ± 0.137 g/cm 2 ; p  = 0.024) and both relative (9.94 vs. 3.94%; p  &lt; 0.001) and absolute (0.09 ± 0.06 vs. 0.03 ± 0.04 g/cm 2 ; p  &lt; 0.001) changes in lumbar-spine BMD were significantly higher in the SG than in the PG. Compared to baseline, BMD significantly increased in both groups at the lumbar spine ( p  &lt; 0.001 and p  = 0.001, respectively) and femoral neck (both p  &lt; 0.001), whereas radius BMD only changed significantly in the SG. However, the proportion of patients with osteoporosis/osteopenia significantly declined only at the lumbar spine in the SG (from 69.0 to 37.9%; p  = 0.034), whereas no decrease was found in the PG. No severe adverse events occurred. Conclusions Postoperative anti-osteoporotic treatment can positively influence regain of BMD mainly in the lumbar spine and should be considered. 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Public Health</topic><topic>Middle Aged</topic><topic>Osteoporosis - drug therapy</topic><topic>Osteoporosis - etiology</topic><topic>Parathyroidectomy</topic><topic>Thiophenes - therapeutic use</topic><topic>Thoracic Surgery</topic><topic>Traumatic Surgery</topic><topic>Vascular Surgery</topic><topic>Vitamin D - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Niederle, Martin B.</creatorcontrib><creatorcontrib>Foeger-Samwald, Ursula</creatorcontrib><creatorcontrib>Riss, Philipp</creatorcontrib><creatorcontrib>Selberherr, Andreas</creatorcontrib><creatorcontrib>Scheuba, Christian</creatorcontrib><creatorcontrib>Pietschmann, Peter</creatorcontrib><creatorcontrib>Niederle, Bruno</creatorcontrib><creatorcontrib>Kerschan-Schindl, Katharina</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Langenbeck's archives of surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Niederle, Martin B.</au><au>Foeger-Samwald, Ursula</au><au>Riss, Philipp</au><au>Selberherr, Andreas</au><au>Scheuba, Christian</au><au>Pietschmann, Peter</au><au>Niederle, Bruno</au><au>Kerschan-Schindl, Katharina</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness of anti-osteoporotic treatment after successful parathyroidectomy for primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial</atitle><jtitle>Langenbeck's archives of surgery</jtitle><stitle>Langenbecks Arch Surg</stitle><addtitle>Langenbecks Arch Surg</addtitle><date>2019-09-01</date><risdate>2019</risdate><volume>404</volume><issue>6</issue><spage>681</spage><epage>691</epage><pages>681-691</pages><issn>1435-2443</issn><issn>1435-2451</issn><eissn>1435-2451</eissn><abstract>Purpose After successful surgery for primary hyperparathyroidism, bone mineral density (BMD) does not improve equally in all patients. As no trial has so far aimed to influence normalization of BMD, it was the goal of this investigation to determine whether pharmacological treatment is effective in improving regain of BMD after successful parathyroidectomy in patients with preoperatively diagnosed osteoporosis or osteopenia and to evaluate when treatment may be indicated. Methods In this randomized, placebo-controlled, double-blind trial, 52 patients were treated with strontium ranelate 2 g daily + 1000 mg calcium + 800 IU vitamin D (strontium group; SG) or with 1000 mg calcium + 800 IU vitamin D alone (placebo group; PG) for 1 year. The main outcome measures were BMD (lumbar spine, femoral neck, radius) and bone turnover markers. Results The baseline characteristics were similar in both groups. Absolute BMD (1.007 ± 0.197 vs. 0.897 ± 0.137 g/cm 2 ; p  = 0.024) and both relative (9.94 vs. 3.94%; p  &lt; 0.001) and absolute (0.09 ± 0.06 vs. 0.03 ± 0.04 g/cm 2 ; p  &lt; 0.001) changes in lumbar-spine BMD were significantly higher in the SG than in the PG. Compared to baseline, BMD significantly increased in both groups at the lumbar spine ( p  &lt; 0.001 and p  = 0.001, respectively) and femoral neck (both p  &lt; 0.001), whereas radius BMD only changed significantly in the SG. However, the proportion of patients with osteoporosis/osteopenia significantly declined only at the lumbar spine in the SG (from 69.0 to 37.9%; p  = 0.034), whereas no decrease was found in the PG. No severe adverse events occurred. Conclusions Postoperative anti-osteoporotic treatment can positively influence regain of BMD mainly in the lumbar spine and should be considered. Without treatment, most patients and especially those with low preoperative markers of bone turnover remained osteoporotic/osteopenic 1 year after surgery.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>31451913</pmid><doi>10.1007/s00423-019-01815-9</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0003-0450-6132</orcidid><oa>free_for_read</oa></addata></record>
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subjects Abdominal Surgery
Bone Density - drug effects
Bone Diseases, Metabolic - drug therapy
Bone Diseases, Metabolic - etiology
Bone Remodeling
Calcium - therapeutic use
Cardiac Surgery
Controlled Clinical Trial
Double-Blind Method
Female
General Surgery
Humans
Hyperparathyroidism, Primary - complications
Hyperparathyroidism, Primary - surgery
Male
Medicine
Medicine & Public Health
Middle Aged
Osteoporosis - drug therapy
Osteoporosis - etiology
Parathyroidectomy
Thiophenes - therapeutic use
Thoracic Surgery
Traumatic Surgery
Vascular Surgery
Vitamin D - therapeutic use
title Effectiveness of anti-osteoporotic treatment after successful parathyroidectomy for primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial
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