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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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 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6906217</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2281111061</sourcerecordid><originalsourceid>FETCH-LOGICAL-c446t-7ffdc754f1d463f486fb5cd48bb93c40c452a443cef8591f3bb60fd078ec2db3</originalsourceid><addsrcrecordid>eNp9kcuOFSEQhjtG44yjL-DCsHRhKzT0zYWJmYyXZBI3sydcijlMaKoFepLj-_ieoud4Mm4kIUDqq7-o-pvmJaNvGaXju0yp6HhL2Vz3xPp2ftScM8H7thM9e3y6C37WPMv5jlI6jLN42pxxVoGZ8fPm55VzYIq_hwg5E3RExeJbzAVwxYTFG1ISqLJALES5AonkzZgKuy2QVSVVdvuE3lYVXPbEYSJr8otKe7Lbr5AeID4v74kiSUWLi_8B9g2xuOkArQ4-1tcalAGNrcFYEoYAthb3KjxvnjgVMrw4nhfNzaerm8sv7fW3z18vP163RoihtKNz1oy9cMyKgTsxDU73xopJ65kbQY3oO1XHYcBN_cwc13qgztJxAtNZzS-aDwfZddMLWFNbTirIYzsSlZf_RqLfyVu8l8NMh46NVeD1USDh9w1ykYvPBkJQEXDLsusmVhcdWEW7A2oS5pzAncowKn_bKw_2ymqv_GOvnGvSq4cfPKX89bMC_ADkGoq3kOQdbinWmf1P9hfddrhY</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2281111061</pqid></control><display><type>article</type><title>Effectiveness of anti-osteoporotic treatment after successful parathyroidectomy for primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Niederle, Martin B. ; Foeger-Samwald, Ursula ; Riss, Philipp ; Selberherr, Andreas ; Scheuba, Christian ; Pietschmann, Peter ; Niederle, Bruno ; Kerschan-Schindl, Katharina</creator><creatorcontrib>Niederle, Martin B. ; Foeger-Samwald, Ursula ; Riss, Philipp ; Selberherr, Andreas ; Scheuba, Christian ; Pietschmann, Peter ; Niederle, Bruno ; Kerschan-Schindl, Katharina</creatorcontrib><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
< 0.001) and absolute (0.09 ± 0.06 vs. 0.03 ± 0.04 g/cm
2
;
p
< 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
< 0.001 and
p
= 0.001, respectively) and femoral neck (both
p
< 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 & 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
< 0.001) and absolute (0.09 ± 0.06 vs. 0.03 ± 0.04 g/cm
2
;
p
< 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
< 0.001 and
p
= 0.001, respectively) and femoral neck (both
p
< 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><subject>Abdominal Surgery</subject><subject>Bone Density - drug effects</subject><subject>Bone Diseases, Metabolic - drug therapy</subject><subject>Bone Diseases, Metabolic - etiology</subject><subject>Bone Remodeling</subject><subject>Calcium - therapeutic use</subject><subject>Cardiac Surgery</subject><subject>Controlled Clinical Trial</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>General Surgery</subject><subject>Humans</subject><subject>Hyperparathyroidism, Primary - complications</subject><subject>Hyperparathyroidism, Primary - surgery</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Osteoporosis - drug therapy</subject><subject>Osteoporosis - etiology</subject><subject>Parathyroidectomy</subject><subject>Thiophenes - therapeutic use</subject><subject>Thoracic Surgery</subject><subject>Traumatic Surgery</subject><subject>Vascular Surgery</subject><subject>Vitamin D - therapeutic use</subject><issn>1435-2443</issn><issn>1435-2451</issn><issn>1435-2451</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><recordid>eNp9kcuOFSEQhjtG44yjL-DCsHRhKzT0zYWJmYyXZBI3sydcijlMaKoFepLj-_ieoud4Mm4kIUDqq7-o-pvmJaNvGaXju0yp6HhL2Vz3xPp2ftScM8H7thM9e3y6C37WPMv5jlI6jLN42pxxVoGZ8fPm55VzYIq_hwg5E3RExeJbzAVwxYTFG1ISqLJALES5AonkzZgKuy2QVSVVdvuE3lYVXPbEYSJr8otKe7Lbr5AeID4v74kiSUWLi_8B9g2xuOkArQ4-1tcalAGNrcFYEoYAthb3KjxvnjgVMrw4nhfNzaerm8sv7fW3z18vP163RoihtKNz1oy9cMyKgTsxDU73xopJ65kbQY3oO1XHYcBN_cwc13qgztJxAtNZzS-aDwfZddMLWFNbTirIYzsSlZf_RqLfyVu8l8NMh46NVeD1USDh9w1ykYvPBkJQEXDLsusmVhcdWEW7A2oS5pzAncowKn_bKw_2ymqv_GOvnGvSq4cfPKX89bMC_ADkGoq3kOQdbinWmf1P9hfddrhY</recordid><startdate>20190901</startdate><enddate>20190901</enddate><creator>Niederle, Martin B.</creator><creator>Foeger-Samwald, Ursula</creator><creator>Riss, Philipp</creator><creator>Selberherr, Andreas</creator><creator>Scheuba, Christian</creator><creator>Pietschmann, Peter</creator><creator>Niederle, Bruno</creator><creator>Kerschan-Schindl, Katharina</creator><general>Springer Berlin Heidelberg</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-0450-6132</orcidid></search><sort><creationdate>20190901</creationdate><title>Effectiveness of anti-osteoporotic treatment after successful parathyroidectomy for primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial</title><author>Niederle, Martin B. ; Foeger-Samwald, Ursula ; Riss, Philipp ; Selberherr, Andreas ; Scheuba, Christian ; Pietschmann, Peter ; Niederle, Bruno ; Kerschan-Schindl, Katharina</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c446t-7ffdc754f1d463f486fb5cd48bb93c40c452a443cef8591f3bb60fd078ec2db3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Abdominal Surgery</topic><topic>Bone Density - drug effects</topic><topic>Bone Diseases, Metabolic - drug therapy</topic><topic>Bone Diseases, Metabolic - etiology</topic><topic>Bone Remodeling</topic><topic>Calcium - therapeutic use</topic><topic>Cardiac Surgery</topic><topic>Controlled Clinical Trial</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>General Surgery</topic><topic>Humans</topic><topic>Hyperparathyroidism, Primary - complications</topic><topic>Hyperparathyroidism, Primary - surgery</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & 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
< 0.001) and absolute (0.09 ± 0.06 vs. 0.03 ± 0.04 g/cm
2
;
p
< 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
< 0.001 and
p
= 0.001, respectively) and femoral neck (both
p
< 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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source | MEDLINE; SpringerLink Journals - AutoHoldings |
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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