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A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

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A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density. / Orwoll, Eric; Teglbjærg, Christence S; Langdahl, Bente Lomholt; Chapurlat, Roland; Czerwinski, Edward; Kendler, David L; Reginster, Jean-Yves; Kivitz, Alan; Lewiecki, E Michael; Miller, Paul D; Bolognese, Michael A; McClung, Michael R; Bone, Henry G; Ljunggren, Osten; Abrahamsen, Bo; Gruntmanis, Ugis; Yang, Yu-Ching; Wagman, Rachel B; Siddhanti, Suresh; Grauer, Andreas; Hall, Jesse W; Boonen, Steven.

I: Journal of Clinical Endocrinology and Metabolism, Bind 97, Nr. 9, 2012, s. 3161-9.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Harvard

Orwoll, E, Teglbjærg, CS, Langdahl, BL, Chapurlat, R, Czerwinski, E, Kendler, DL, Reginster, J-Y, Kivitz, A, Lewiecki, EM, Miller, PD, Bolognese, MA, McClung, MR, Bone, HG, Ljunggren, O, Abrahamsen, B, Gruntmanis, U, Yang, Y-C, Wagman, RB, Siddhanti, S, Grauer, A, Hall, JW & Boonen, S 2012, 'A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density', Journal of Clinical Endocrinology and Metabolism, bind 97, nr. 9, s. 3161-9. https://doi.org/10.1210/jc.2012-1569

APA

Orwoll, E., Teglbjærg, C. S., Langdahl, B. L., Chapurlat, R., Czerwinski, E., Kendler, D. L., ... Boonen, S. (2012). A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density. Journal of Clinical Endocrinology and Metabolism, 97(9), 3161-9. https://doi.org/10.1210/jc.2012-1569

Vancouver

Orwoll E, Teglbjærg CS, Langdahl BL, Chapurlat R, Czerwinski E, Kendler DL o.a. A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density. Journal of Clinical Endocrinology and Metabolism. 2012;97(9):3161-9. https://doi.org/10.1210/jc.2012-1569

Author

Orwoll, Eric ; Teglbjærg, Christence S ; Langdahl, Bente Lomholt ; Chapurlat, Roland ; Czerwinski, Edward ; Kendler, David L ; Reginster, Jean-Yves ; Kivitz, Alan ; Lewiecki, E Michael ; Miller, Paul D ; Bolognese, Michael A ; McClung, Michael R ; Bone, Henry G ; Ljunggren, Osten ; Abrahamsen, Bo ; Gruntmanis, Ugis ; Yang, Yu-Ching ; Wagman, Rachel B ; Siddhanti, Suresh ; Grauer, Andreas ; Hall, Jesse W ; Boonen, Steven. / A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density. I: Journal of Clinical Endocrinology and Metabolism. 2012 ; Bind 97, Nr. 9. s. 3161-9.

Bibtex

@article{5029ff58447742e28d761d495044f089,
title = "A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density",
abstract = "Context: Men with low bone mineral density (BMD) were treated with denosumab. Objective: Our objective was to investigate the effects of denosumab compared with placebo in men with low BMD after 1 yr of treatment. Design, Subjects, and Intervention: This was a placebo-controlled, phase 3 study to investigate the efficacy and safety of denosumab 60 mg every 6 months vs. placebo in men with low BMD. Main Outcome Measure: The primary endpoint was the percent change from baseline in lumbar spine (LS) BMD at month 12. Results: Of the 242 randomized subjects (mean age 65 yr), 228 (94.2{\%}) completed 1 yr of denosumab therapy. After 12 months, denosumab resulted in BMD increases of 5.7{\%} at the LS, 2.4{\%} at the total hip, 2.1{\%} at the femoral neck, 3.1{\%} at the trochanter, and 0.6{\%} at the one third radius (adjusted P ≤ 0.0144 for BMD percent differences at all sites compared with placebo). Sensitivity analyses done by controlling for baseline covariates (such as baseline testosterone levels, BMD T-scores, and 10-yr osteoporotic fracture risk) demonstrated that the results of the primary endpoint were robust. Subgroup analyses indicate that treatment with denosumab was effective across a spectrum of clinical situations. Treatment with denosumab significantly reduced serum CTX levels at d 15 (adjusted P <0.0001). The incidence of adverse events was similar between groups. Conclusions: One year of denosumab therapy in men with low BMD was well tolerated and resulted in a reduction in bone resorption and significant increases in BMD at all skeletal sites assessed.",
author = "Eric Orwoll and Teglbj{\ae}rg, {Christence S} and Langdahl, {Bente Lomholt} and Roland Chapurlat and Edward Czerwinski and Kendler, {David L} and Jean-Yves Reginster and Alan Kivitz and Lewiecki, {E Michael} and Miller, {Paul D} and Bolognese, {Michael A} and McClung, {Michael R} and Bone, {Henry G} and Osten Ljunggren and Bo Abrahamsen and Ugis Gruntmanis and Yu-Ching Yang and Wagman, {Rachel B} and Suresh Siddhanti and Andreas Grauer and Hall, {Jesse W} and Steven Boonen",
year = "2012",
doi = "10.1210/jc.2012-1569",
language = "English",
volume = "97",
pages = "3161--9",
journal = "Journal of Clinical Endocrinology and Metabolism",
issn = "0021-972X",
publisher = "Oxford University Press",
number = "9",

}

RIS

TY - JOUR

T1 - A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density

AU - Orwoll, Eric

AU - Teglbjærg, Christence S

AU - Langdahl, Bente Lomholt

AU - Chapurlat, Roland

AU - Czerwinski, Edward

AU - Kendler, David L

AU - Reginster, Jean-Yves

AU - Kivitz, Alan

AU - Lewiecki, E Michael

AU - Miller, Paul D

AU - Bolognese, Michael A

AU - McClung, Michael R

AU - Bone, Henry G

AU - Ljunggren, Osten

AU - Abrahamsen, Bo

AU - Gruntmanis, Ugis

AU - Yang, Yu-Ching

AU - Wagman, Rachel B

AU - Siddhanti, Suresh

AU - Grauer, Andreas

AU - Hall, Jesse W

AU - Boonen, Steven

PY - 2012

Y1 - 2012

N2 - Context: Men with low bone mineral density (BMD) were treated with denosumab. Objective: Our objective was to investigate the effects of denosumab compared with placebo in men with low BMD after 1 yr of treatment. Design, Subjects, and Intervention: This was a placebo-controlled, phase 3 study to investigate the efficacy and safety of denosumab 60 mg every 6 months vs. placebo in men with low BMD. Main Outcome Measure: The primary endpoint was the percent change from baseline in lumbar spine (LS) BMD at month 12. Results: Of the 242 randomized subjects (mean age 65 yr), 228 (94.2%) completed 1 yr of denosumab therapy. After 12 months, denosumab resulted in BMD increases of 5.7% at the LS, 2.4% at the total hip, 2.1% at the femoral neck, 3.1% at the trochanter, and 0.6% at the one third radius (adjusted P ≤ 0.0144 for BMD percent differences at all sites compared with placebo). Sensitivity analyses done by controlling for baseline covariates (such as baseline testosterone levels, BMD T-scores, and 10-yr osteoporotic fracture risk) demonstrated that the results of the primary endpoint were robust. Subgroup analyses indicate that treatment with denosumab was effective across a spectrum of clinical situations. Treatment with denosumab significantly reduced serum CTX levels at d 15 (adjusted P <0.0001). The incidence of adverse events was similar between groups. Conclusions: One year of denosumab therapy in men with low BMD was well tolerated and resulted in a reduction in bone resorption and significant increases in BMD at all skeletal sites assessed.

AB - Context: Men with low bone mineral density (BMD) were treated with denosumab. Objective: Our objective was to investigate the effects of denosumab compared with placebo in men with low BMD after 1 yr of treatment. Design, Subjects, and Intervention: This was a placebo-controlled, phase 3 study to investigate the efficacy and safety of denosumab 60 mg every 6 months vs. placebo in men with low BMD. Main Outcome Measure: The primary endpoint was the percent change from baseline in lumbar spine (LS) BMD at month 12. Results: Of the 242 randomized subjects (mean age 65 yr), 228 (94.2%) completed 1 yr of denosumab therapy. After 12 months, denosumab resulted in BMD increases of 5.7% at the LS, 2.4% at the total hip, 2.1% at the femoral neck, 3.1% at the trochanter, and 0.6% at the one third radius (adjusted P ≤ 0.0144 for BMD percent differences at all sites compared with placebo). Sensitivity analyses done by controlling for baseline covariates (such as baseline testosterone levels, BMD T-scores, and 10-yr osteoporotic fracture risk) demonstrated that the results of the primary endpoint were robust. Subgroup analyses indicate that treatment with denosumab was effective across a spectrum of clinical situations. Treatment with denosumab significantly reduced serum CTX levels at d 15 (adjusted P <0.0001). The incidence of adverse events was similar between groups. Conclusions: One year of denosumab therapy in men with low BMD was well tolerated and resulted in a reduction in bone resorption and significant increases in BMD at all skeletal sites assessed.

U2 - 10.1210/jc.2012-1569

DO - 10.1210/jc.2012-1569

M3 - Journal article

C2 - 22723310

VL - 97

SP - 3161

EP - 3169

JO - Journal of Clinical Endocrinology and Metabolism

JF - Journal of Clinical Endocrinology and Metabolism

SN - 0021-972X

IS - 9

ER -

ID: 48413834