Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation

Takanori Yamamoto,1 Mika Tsujimoto,2 Hideaki Sowa11Medical Science, Lilly Research Laboratories, Medicines Development Unit Japan, 2Asia Pacific Statistical Science-Japan, Science and Regulatory Affairs, LRL MDU-Japan, Eli Lilly Japan K.K, Kobe, Hyogo, JapanObjective: Serum procollagen type I N-term...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Yamamoto T, Tsujimoto M, Sowa H
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2015
Materias:	Teriparatide Osteoporosis Hypercalcemia Procollagen type I N-terminal propeptide Bone metabolism markers Geriatrics RC952-954.6
Acceso en línea:	https://doaj.org/article/94273f42741147579a3ef76d1f06d2e3
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:94273f42741147579a3ef76d1f06d2e3
record_format	dspace
spelling	oai:doaj.org-article:94273f42741147579a3ef76d1f06d2e32021-12-02T06:46:31ZSafety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation1178-1998https://doaj.org/article/94273f42741147579a3ef76d1f06d2e32015-07-01T00:00:00Zhttps://www.dovepress.com/safety-of-daily-teriparatide-treatment-a-post-hoc-analysis-of-a-phase--peer-reviewed-article-CIAhttps://doaj.org/toc/1178-1998Takanori Yamamoto,1 Mika Tsujimoto,2 Hideaki Sowa11Medical Science, Lilly Research Laboratories, Medicines Development Unit Japan, 2Asia Pacific Statistical Science-Japan, Science and Regulatory Affairs, LRL MDU-Japan, Eli Lilly Japan K.K, Kobe, Hyogo, JapanObjective: Serum procollagen type I N-terminal propeptide (PINP), a representative marker of bone anabolic action, is strongly related to bone mineral density during teriparatide therapy. This post hoc study analyzed data from a Phase III study (ClinicalTrials.gov identifier NCT00433160) to determine if there was an association between serum PINP elevation and serum calcium concentration or calcium metabolism-related disorders.Research design and methods: Japanese subjects with osteoporosis at high risk of fracture were randomized 2:1 to teriparatide 20 µg/day (n=137) or placebo (n=70) for a 12-month double-blind treatment period, followed by 12 months of open-label teriparatide treatment of all subjects.Main outcome measures: Serum PINP levels were measured at baseline, and after 1, 3, 6, 12, 18, and 24 months of treatment. Serum calcium levels were measured at baseline, and after 1, 3, 6, 9, 12, 15, 18, 21, and 24 months of treatment.Results: Serum PINP increased from baseline to 1 month of treatment and then remained high through 24 months. Twenty-eight of 195 subjects experienced PINP elevations >200 µg/L during teriparatide treatment. Serum calcium concentration in both the teriparatide and placebo groups remained within the normal range. There was no clinically relevant difference in serum calcium concentration between subjects with PINP >200 µg/L and subjects with PINP ≤200 µg/L. Two subjects experienced hypercalcemia and recovered without altering teriparatide treatment. Adverse events possibly related to calcium metabolism disorders included periarthritis calcarea (one subject) and chondrocalcinosis pyrophosphate (two subjects), but neither was accompanied with a significant increase in PINP or serum calcium concentration.Conclusion: Although the moderate size of this study prevented statistical analysis of any potential association between calcium metabolism-related disorders and elevated PINP, this analysis suggests that there was no association between serum PINP elevation during daily teriparatide treatment and serum calcium concentration or calcium metabolism-related disorders in Japanese subjects.Keywords: teriparatide, osteoporosis, hypercalcemia, procollagen type I N-terminal propeptide, bone metabolism markersYamamoto TTsujimoto MSowa HDove Medical PressarticleTeriparatideOsteoporosisHypercalcemiaProcollagen type I N-terminal propeptideBone metabolism markersGeriatricsRC952-954.6ENClinical Interventions in Aging, Vol Volume 10, Pp 1101-1109 (2015)
institution	DOAJ
collection	DOAJ
language	EN
topic	Teriparatide Osteoporosis Hypercalcemia Procollagen type I N-terminal propeptide Bone metabolism markers Geriatrics RC952-954.6
spellingShingle	Teriparatide Osteoporosis Hypercalcemia Procollagen type I N-terminal propeptide Bone metabolism markers Geriatrics RC952-954.6 Yamamoto T Tsujimoto M Sowa H Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation
description	Takanori Yamamoto,1 Mika Tsujimoto,2 Hideaki Sowa11Medical Science, Lilly Research Laboratories, Medicines Development Unit Japan, 2Asia Pacific Statistical Science-Japan, Science and Regulatory Affairs, LRL MDU-Japan, Eli Lilly Japan K.K, Kobe, Hyogo, JapanObjective: Serum procollagen type I N-terminal propeptide (PINP), a representative marker of bone anabolic action, is strongly related to bone mineral density during teriparatide therapy. This post hoc study analyzed data from a Phase III study (ClinicalTrials.gov identifier NCT00433160) to determine if there was an association between serum PINP elevation and serum calcium concentration or calcium metabolism-related disorders.Research design and methods: Japanese subjects with osteoporosis at high risk of fracture were randomized 2:1 to teriparatide 20 µg/day (n=137) or placebo (n=70) for a 12-month double-blind treatment period, followed by 12 months of open-label teriparatide treatment of all subjects.Main outcome measures: Serum PINP levels were measured at baseline, and after 1, 3, 6, 12, 18, and 24 months of treatment. Serum calcium levels were measured at baseline, and after 1, 3, 6, 9, 12, 15, 18, 21, and 24 months of treatment.Results: Serum PINP increased from baseline to 1 month of treatment and then remained high through 24 months. Twenty-eight of 195 subjects experienced PINP elevations >200 µg/L during teriparatide treatment. Serum calcium concentration in both the teriparatide and placebo groups remained within the normal range. There was no clinically relevant difference in serum calcium concentration between subjects with PINP >200 µg/L and subjects with PINP ≤200 µg/L. Two subjects experienced hypercalcemia and recovered without altering teriparatide treatment. Adverse events possibly related to calcium metabolism disorders included periarthritis calcarea (one subject) and chondrocalcinosis pyrophosphate (two subjects), but neither was accompanied with a significant increase in PINP or serum calcium concentration.Conclusion: Although the moderate size of this study prevented statistical analysis of any potential association between calcium metabolism-related disorders and elevated PINP, this analysis suggests that there was no association between serum PINP elevation during daily teriparatide treatment and serum calcium concentration or calcium metabolism-related disorders in Japanese subjects.Keywords: teriparatide, osteoporosis, hypercalcemia, procollagen type I N-terminal propeptide, bone metabolism markers
format	article
author	Yamamoto T Tsujimoto M Sowa H
author_facet	Yamamoto T Tsujimoto M Sowa H
author_sort	Yamamoto T
title	Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation
title_short	Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation
title_full	Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation
title_fullStr	Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation
title_full_unstemmed	Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation
title_sort	safety of daily teriparatide treatment: a post hoc analysis of a phase iii study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type i n-terminal propeptide elevation
publisher	Dove Medical Press
publishDate	2015
url	https://doaj.org/article/94273f42741147579a3ef76d1f06d2e3
work_keys_str_mv	AT yamamotot safetyofdailyteriparatidetreatmentaposthocanalysisofaphaseiiistudytoinvestigatethepossibleassociationofteriparatidetreatmentwithcalciumhomeostasisinpatientswithserumprocollagentypeinterminalpropeptideelevation AT tsujimotom safetyofdailyteriparatidetreatmentaposthocanalysisofaphaseiiistudytoinvestigatethepossibleassociationofteriparatidetreatmentwithcalciumhomeostasisinpatientswithserumprocollagentypeinterminalpropeptideelevation AT sowah safetyofdailyteriparatidetreatmentaposthocanalysisofaphaseiiistudytoinvestigatethepossibleassociationofteriparatidetreatmentwithcalciumhomeostasisinpatientswithserumprocollagentypeinterminalpropeptideelevation
_version_	1718399765729771520

Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation

Ejemplares similares