Randomised controlled study of effect of parathyroid hormone on vertebral-bone mass and fracture incidence among postmenopausal women on oestrogen with osteoporosis
Small increases in bone mass are commonly seen with existing treatments for osteoporosis, which reduce bone remodelling and primarily prevent bone loss. Since these drugs reduce but do not eliminate risk of fractures, an anabolic agent that would increase bone mass and potentially cure the underlyin...
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Veröffentlicht in: | The Lancet (British edition) 1997-08, Vol.350 (9077), p.550-555 |
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description | Small increases in bone mass are commonly seen with existing treatments for osteoporosis, which reduce bone remodelling and primarily prevent bone loss. Since these drugs reduce but do not eliminate risk of fractures, an anabolic agent that would increase bone mass and potentially cure the underlying skeletal problem is needed.
We did a 3-year randomised controlled trial to find out the effects of 1–34 human parathyroid hormone (hPTH [1–34], 400 U/25 μg daily subcutaneously) in postmenopausal women with osteoporosis taking hormone-replacement therapy (n=17). The controls were women taking hormone-replacement therapy only (n=17). The primary outcome was bone-mineral density of the lumbar vertebrae, with bone-mineral density at other sites and vertebral fractures as secondary endpoints.
Patients taking hormone-replacement therapy and PTH (1–34) had continuous increase in vertebral bone-mineral density during the 3 years, whereas there was no significant change in the control group. The total increase in vertebral bone-mineral density was 13·0% (p |
doi_str_mv | 10.1016/S0140-6736(97)02342-8 |
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We did a 3-year randomised controlled trial to find out the effects of 1–34 human parathyroid hormone (hPTH [1–34], 400 U/25 μg daily subcutaneously) in postmenopausal women with osteoporosis taking hormone-replacement therapy (n=17). The controls were women taking hormone-replacement therapy only (n=17). The primary outcome was bone-mineral density of the lumbar vertebrae, with bone-mineral density at other sites and vertebral fractures as secondary endpoints.
Patients taking hormone-replacement therapy and PTH (1–34) had continuous increase in vertebral bone-mineral density during the 3 years, whereas there was no significant change in the control group. The total increase in vertebral bone-mineral density was 13·0% (p<0·001); 2·7% at the hip (p=0·05); and 8·0% in total-body bone mineral (p=0·002). No loss of bone mass was found at any skeletal site. Increased bone mass was associated with a reduction in the rate of vertebral fractures, which was significant when fractures were taken as a 15% reduction in vertebral height (p=0·04). During the first 6 months of treatment, serum osteocalcin concentration, which reflects bone formation, increased by more than 55%, whereas excretion of crosslinked n-telopeptide, which reflects bone resorption, increased by only 20%, which suggests some uncoupling of bone formation and resorption. By 6 months, there were similar increases in both markers, which gradually returned towards baseline as the study progressed. Vertebral bone-mineral density increased most during the first year of PTH treatment.
We found that PTH has a pronouned anabolic effect on the central skeleton in patients on hormone-replacement therapy. PTH also increases total-body bone mineral, with no detrimental effects at any skeletal site. The increased vertebral mass was associated with a reduced rate of vertebral fracture, despite increased bone turnover. Bone-mass changes may be consistent with a reduction in all osteoporotic fractures. If confirmed in larger studies, these data have important implications for the treatment of postmenopausal osteoporosis.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(97)02342-8</identifier><identifier>PMID: 9284777</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>London: Elsevier Ltd</publisher><subject>Absorptiometry, Photon ; Aged ; Biological and medical sciences ; Biomarkers - analysis ; Bone Density - drug effects ; Bones ; Drug therapy ; Estrogen Replacement Therapy ; Estrogens - therapeutic use ; Female ; Fractures, Bone - epidemiology ; Fractures, Bone - prevention & control ; Hormones ; Hormones. Endocrine system ; Humans ; Incidence ; Medical sciences ; Menopause ; Middle Aged ; Osteoporosis ; Osteoporosis, Postmenopausal - drug therapy ; Osteoporosis, Postmenopausal - physiopathology ; Pharmacology. Drug treatments ; Postmenopause ; Spine ; Teriparatide - pharmacology ; Teriparatide - therapeutic use ; Women</subject><ispartof>The Lancet (British edition), 1997-08, Vol.350 (9077), p.550-555</ispartof><rights>1997 Elsevier Ltd</rights><rights>1997 INIST-CNRS</rights><rights>Copyright Lancet Ltd. Aug 23, 1997</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c463t-173676ae7fae64b69ccb94008950bda5f5111efab739253660274b6db2ddd3ef3</citedby><cites>FETCH-LOGICAL-c463t-173676ae7fae64b69ccb94008950bda5f5111efab739253660274b6db2ddd3ef3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/199035581?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2777126$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9284777$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lindsay, Robert</creatorcontrib><creatorcontrib>Nieves, Jeri</creatorcontrib><creatorcontrib>Formica, Carmelo</creatorcontrib><creatorcontrib>Henneman, Emily</creatorcontrib><creatorcontrib>Woelfert, Lillian</creatorcontrib><creatorcontrib>Shen, Victor</creatorcontrib><creatorcontrib>Dempster, David</creatorcontrib><creatorcontrib>Cosman, Felicia</creatorcontrib><title>Randomised controlled study of effect of parathyroid hormone on vertebral-bone mass and fracture incidence among postmenopausal women on oestrogen with osteoporosis</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Small increases in bone mass are commonly seen with existing treatments for osteoporosis, which reduce bone remodelling and primarily prevent bone loss. Since these drugs reduce but do not eliminate risk of fractures, an anabolic agent that would increase bone mass and potentially cure the underlying skeletal problem is needed.
We did a 3-year randomised controlled trial to find out the effects of 1–34 human parathyroid hormone (hPTH [1–34], 400 U/25 μg daily subcutaneously) in postmenopausal women with osteoporosis taking hormone-replacement therapy (n=17). The controls were women taking hormone-replacement therapy only (n=17). The primary outcome was bone-mineral density of the lumbar vertebrae, with bone-mineral density at other sites and vertebral fractures as secondary endpoints.
Patients taking hormone-replacement therapy and PTH (1–34) had continuous increase in vertebral bone-mineral density during the 3 years, whereas there was no significant change in the control group. The total increase in vertebral bone-mineral density was 13·0% (p<0·001); 2·7% at the hip (p=0·05); and 8·0% in total-body bone mineral (p=0·002). No loss of bone mass was found at any skeletal site. Increased bone mass was associated with a reduction in the rate of vertebral fractures, which was significant when fractures were taken as a 15% reduction in vertebral height (p=0·04). During the first 6 months of treatment, serum osteocalcin concentration, which reflects bone formation, increased by more than 55%, whereas excretion of crosslinked n-telopeptide, which reflects bone resorption, increased by only 20%, which suggests some uncoupling of bone formation and resorption. By 6 months, there were similar increases in both markers, which gradually returned towards baseline as the study progressed. Vertebral bone-mineral density increased most during the first year of PTH treatment.
We found that PTH has a pronouned anabolic effect on the central skeleton in patients on hormone-replacement therapy. PTH also increases total-body bone mineral, with no detrimental effects at any skeletal site. The increased vertebral mass was associated with a reduced rate of vertebral fracture, despite increased bone turnover. Bone-mass changes may be consistent with a reduction in all osteoporotic fractures. If confirmed in larger studies, these data have important implications for the treatment of postmenopausal osteoporosis.</description><subject>Absorptiometry, Photon</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Biomarkers - analysis</subject><subject>Bone Density - drug effects</subject><subject>Bones</subject><subject>Drug therapy</subject><subject>Estrogen Replacement Therapy</subject><subject>Estrogens - therapeutic use</subject><subject>Female</subject><subject>Fractures, Bone - epidemiology</subject><subject>Fractures, Bone - prevention & control</subject><subject>Hormones</subject><subject>Hormones. Endocrine system</subject><subject>Humans</subject><subject>Incidence</subject><subject>Medical sciences</subject><subject>Menopause</subject><subject>Middle Aged</subject><subject>Osteoporosis</subject><subject>Osteoporosis, Postmenopausal - drug therapy</subject><subject>Osteoporosis, Postmenopausal - physiopathology</subject><subject>Pharmacology. 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Endocrine system</topic><topic>Humans</topic><topic>Incidence</topic><topic>Medical sciences</topic><topic>Menopause</topic><topic>Middle Aged</topic><topic>Osteoporosis</topic><topic>Osteoporosis, Postmenopausal - drug therapy</topic><topic>Osteoporosis, Postmenopausal - physiopathology</topic><topic>Pharmacology. 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Academic</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lindsay, Robert</au><au>Nieves, Jeri</au><au>Formica, Carmelo</au><au>Henneman, Emily</au><au>Woelfert, Lillian</au><au>Shen, Victor</au><au>Dempster, David</au><au>Cosman, Felicia</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomised controlled study of effect of parathyroid hormone on vertebral-bone mass and fracture incidence among postmenopausal women on oestrogen with osteoporosis</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>1997-08-23</date><risdate>1997</risdate><volume>350</volume><issue>9077</issue><spage>550</spage><epage>555</epage><pages>550-555</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Small increases in bone mass are commonly seen with existing treatments for osteoporosis, which reduce bone remodelling and primarily prevent bone loss. Since these drugs reduce but do not eliminate risk of fractures, an anabolic agent that would increase bone mass and potentially cure the underlying skeletal problem is needed.
We did a 3-year randomised controlled trial to find out the effects of 1–34 human parathyroid hormone (hPTH [1–34], 400 U/25 μg daily subcutaneously) in postmenopausal women with osteoporosis taking hormone-replacement therapy (n=17). The controls were women taking hormone-replacement therapy only (n=17). The primary outcome was bone-mineral density of the lumbar vertebrae, with bone-mineral density at other sites and vertebral fractures as secondary endpoints.
Patients taking hormone-replacement therapy and PTH (1–34) had continuous increase in vertebral bone-mineral density during the 3 years, whereas there was no significant change in the control group. The total increase in vertebral bone-mineral density was 13·0% (p<0·001); 2·7% at the hip (p=0·05); and 8·0% in total-body bone mineral (p=0·002). No loss of bone mass was found at any skeletal site. Increased bone mass was associated with a reduction in the rate of vertebral fractures, which was significant when fractures were taken as a 15% reduction in vertebral height (p=0·04). During the first 6 months of treatment, serum osteocalcin concentration, which reflects bone formation, increased by more than 55%, whereas excretion of crosslinked n-telopeptide, which reflects bone resorption, increased by only 20%, which suggests some uncoupling of bone formation and resorption. By 6 months, there were similar increases in both markers, which gradually returned towards baseline as the study progressed. Vertebral bone-mineral density increased most during the first year of PTH treatment.
We found that PTH has a pronouned anabolic effect on the central skeleton in patients on hormone-replacement therapy. PTH also increases total-body bone mineral, with no detrimental effects at any skeletal site. The increased vertebral mass was associated with a reduced rate of vertebral fracture, despite increased bone turnover. Bone-mass changes may be consistent with a reduction in all osteoporotic fractures. If confirmed in larger studies, these data have important implications for the treatment of postmenopausal osteoporosis.</abstract><cop>London</cop><pub>Elsevier Ltd</pub><pmid>9284777</pmid><doi>10.1016/S0140-6736(97)02342-8</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Absorptiometry, Photon Aged Biological and medical sciences Biomarkers - analysis Bone Density - drug effects Bones Drug therapy Estrogen Replacement Therapy Estrogens - therapeutic use Female Fractures, Bone - epidemiology Fractures, Bone - prevention & control Hormones Hormones. Endocrine system Humans Incidence Medical sciences Menopause Middle Aged Osteoporosis Osteoporosis, Postmenopausal - drug therapy Osteoporosis, Postmenopausal - physiopathology Pharmacology. Drug treatments Postmenopause Spine Teriparatide - pharmacology Teriparatide - therapeutic use Women |
title | Randomised controlled study of effect of parathyroid hormone on vertebral-bone mass and fracture incidence among postmenopausal women on oestrogen with osteoporosis |
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