A 24-month study evaluating the efficacy and safety of denosumab for the treatment of men with low bone mineral density: results from the ADAMO trial

Bente L Langdahl; Christence Stubbe Teglbjærg; Pei-Ran Ho; Roland Chapurlat; Edward Czerwinski; David L Kendler; Jean-Yves Reginster; Alan Kivitz; E Michael Lewiecki; Paul D Miller; Michael A Bolognese; Michael R McClung; Henry G Bone; Östen Ljunggren; Bo Abrahamsen; Ugis Gruntmanis; Yu-Ching Yang; Rachel B Wagman; Faisal Mirza; Suresh Siddhanti; Eric Orwoll

doi:10.1210/jc.2014-4079

A 24-month study evaluating the efficacy and safety of denosumab for the treatment of men with low bone mineral density: results from the ADAMO trial

Bente L Langdahl, Christence Stubbe Teglbjærg, Pei-Ran Ho, Roland Chapurlat, Edward Czerwinski, David L Kendler, Jean-Yves Reginster, Alan Kivitz, E Michael Lewiecki, Paul D Miller, Michael A Bolognese, Michael R McClung, Henry G Bone, Östen Ljunggren, Bo Abrahamsen, Ugis Gruntmanis, Yu-Ching Yang, Rachel B Wagman, Faisal Mirza, Suresh SiddhantiEric Orwoll

Medicinsk Afdeling GLO

103 Citationer (Scopus)

Abstract

CONTEXT: One in 4 men in the United States aged >50 years will have an osteoporosis-related fracture. Fewer data are available on osteoporosis treatment in men than in women.

OBJECTIVE: The purpose of this study was to evaluate denosumab therapy in men with low bone mineral density (BMD).

DESIGN: This was a phase 3 study with 2 treatment periods: a previously reported 12-month double-blind, placebo-controlled phase and a 12-month open-label phase.

SETTING: This was a multicenter study conducted in North America and Europe.

PARTICIPANTS: A total of 228 men entered the open-label phase and 219 completed the study.

INTERVENTION: Men from the original denosumab (long-term) and placebo (crossover) groups received 60 mg of denosumab sc every 6 months.

MAIN OUTCOME MEASURES: BMD, serum collagen type I C-telopeptide, and safety were measured.

RESULTS: During the open-label phase, continued BMD increases occurred with long-term denosumab treatment (2.2% lumbar spine, 0.9% total hip, 1.3% femoral neck, 1.3% trochanter, and 0.2% 1/3 radius), resulting in cumulative 24-month gains from baseline of 8.0%, 3.4%, 3.4%, 4.6%, and 0.7%, respectively (all P < .01). The crossover group showed BMD gains after 12 months of denosumab treatment similar to those of the long-term denosumab group during the first treatment year. Significant reductions in serum collagen type I C-teleopeptide were observed after denosumab administration. Adverse event rates were similar between groups, and no new safety signals were identified.

CONCLUSIONS: In men with low BMD, denosumab treatment for a second year continued to increase BMD, maintained reductions in bone resorption, and was well tolerated. BMD increased in men initiating denosumab during the second year. These effects were similar to those previously seen in postmenopausal women with osteoporosis and in men with prostate cancer receiving androgen deprivation therapy.

Originalsprog	Engelsk
Tidsskrift	The Journal of clinical endocrinology and metabolism
Vol/bind	100
Udgave nummer	4
Sider (fra-til)	1335-42
Antal sider	8
ISSN	0021-972X
DOI	https://doi.org/10.1210/jc.2014-4079
Status	Udgivet - apr. 2015

Adgang til dokumentet

10.1210/jc.2014-4079

Citationsformater

Langdahl, B. L., Teglbjærg, C. S., Ho, P.-R., Chapurlat, R., Czerwinski, E., Kendler, D. L., Reginster, J.-Y., Kivitz, A., Lewiecki, E. M., Miller, P. D., Bolognese, M. A., McClung, M. R., Bone, H. G., Ljunggren, Ö., Abrahamsen, B., Gruntmanis, U., Yang, Y.-C., Wagman, R. B., Mirza, F., ... Orwoll, E. (2015). A 24-month study evaluating the efficacy and safety of denosumab for the treatment of men with low bone mineral density: results from the ADAMO trial. The Journal of clinical endocrinology and metabolism, 100(4), 1335-42. https://doi.org/10.1210/jc.2014-4079

A 24-month study evaluating the efficacy and safety of denosumab for the treatment of men with low bone mineral density: results from the ADAMO trial. / Langdahl, Bente L; Teglbjærg, Christence Stubbe; Ho, Pei-Ran et al.
I: The Journal of clinical endocrinology and metabolism, Bind 100, Nr. 4, 04.2015, s. 1335-42.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Langdahl, BL, Teglbjærg, CS, Ho, P-R, Chapurlat, R, Czerwinski, E, Kendler, DL, Reginster, J-Y, Kivitz, A, Lewiecki, EM, Miller, PD, Bolognese, MA, McClung, MR, Bone, HG, Ljunggren, Ö, Abrahamsen, B, Gruntmanis, U, Yang, Y-C, Wagman, RB, Mirza, F, Siddhanti, S & Orwoll, E 2015, 'A 24-month study evaluating the efficacy and safety of denosumab for the treatment of men with low bone mineral density: results from the ADAMO trial', The Journal of clinical endocrinology and metabolism, bind 100, nr. 4, s. 1335-42. https://doi.org/10.1210/jc.2014-4079

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title = "A 24-month study evaluating the efficacy and safety of denosumab for the treatment of men with low bone mineral density: results from the ADAMO trial",

abstract = "CONTEXT: One in 4 men in the United States aged >50 years will have an osteoporosis-related fracture. Fewer data are available on osteoporosis treatment in men than in women.OBJECTIVE: The purpose of this study was to evaluate denosumab therapy in men with low bone mineral density (BMD).DESIGN: This was a phase 3 study with 2 treatment periods: a previously reported 12-month double-blind, placebo-controlled phase and a 12-month open-label phase.SETTING: This was a multicenter study conducted in North America and Europe.PARTICIPANTS: A total of 228 men entered the open-label phase and 219 completed the study.INTERVENTION: Men from the original denosumab (long-term) and placebo (crossover) groups received 60 mg of denosumab sc every 6 months.MAIN OUTCOME MEASURES: BMD, serum collagen type I C-telopeptide, and safety were measured.RESULTS: During the open-label phase, continued BMD increases occurred with long-term denosumab treatment (2.2% lumbar spine, 0.9% total hip, 1.3% femoral neck, 1.3% trochanter, and 0.2% 1/3 radius), resulting in cumulative 24-month gains from baseline of 8.0%, 3.4%, 3.4%, 4.6%, and 0.7%, respectively (all P < .01). The crossover group showed BMD gains after 12 months of denosumab treatment similar to those of the long-term denosumab group during the first treatment year. Significant reductions in serum collagen type I C-teleopeptide were observed after denosumab administration. Adverse event rates were similar between groups, and no new safety signals were identified.CONCLUSIONS: In men with low BMD, denosumab treatment for a second year continued to increase BMD, maintained reductions in bone resorption, and was well tolerated. BMD increased in men initiating denosumab during the second year. These effects were similar to those previously seen in postmenopausal women with osteoporosis and in men with prostate cancer receiving androgen deprivation therapy.",

keywords = "Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Biomarkers, Bone Density, Bone Density Conservation Agents, Denosumab, Femur Neck, Fractures, Bone, Humans, Lumbar Vertebrae, Male, Middle Aged, Osteoporosis, Radius, Treatment Outcome",

author = "Langdahl, {Bente L} and Teglbj{\ae}rg, {Christence Stubbe} and Pei-Ran Ho 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 {\"O}sten Ljunggren and Bo Abrahamsen and Ugis Gruntmanis and Yu-Ching Yang and Wagman, {Rachel B} and Faisal Mirza and Suresh Siddhanti and Eric Orwoll",

year = "2015",

month = apr,

doi = "10.1210/jc.2014-4079",

language = "English",

volume = "100",

pages = "1335--42",

journal = "The Journal of clinical endocrinology and metabolism",

issn = "0021-972X",

publisher = "Endocrine Society",

number = "4",

}

TY - JOUR

T1 - A 24-month study evaluating the efficacy and safety of denosumab for the treatment of men with low bone mineral density

T2 - results from the ADAMO trial

AU - Langdahl, Bente L

AU - Teglbjærg, Christence Stubbe

AU - Ho, Pei-Ran

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, Östen

AU - Abrahamsen, Bo

AU - Gruntmanis, Ugis

AU - Yang, Yu-Ching

AU - Wagman, Rachel B

AU - Mirza, Faisal

AU - Siddhanti, Suresh

AU - Orwoll, Eric

PY - 2015/4

Y1 - 2015/4

N2 - CONTEXT: One in 4 men in the United States aged >50 years will have an osteoporosis-related fracture. Fewer data are available on osteoporosis treatment in men than in women.OBJECTIVE: The purpose of this study was to evaluate denosumab therapy in men with low bone mineral density (BMD).DESIGN: This was a phase 3 study with 2 treatment periods: a previously reported 12-month double-blind, placebo-controlled phase and a 12-month open-label phase.SETTING: This was a multicenter study conducted in North America and Europe.PARTICIPANTS: A total of 228 men entered the open-label phase and 219 completed the study.INTERVENTION: Men from the original denosumab (long-term) and placebo (crossover) groups received 60 mg of denosumab sc every 6 months.MAIN OUTCOME MEASURES: BMD, serum collagen type I C-telopeptide, and safety were measured.RESULTS: During the open-label phase, continued BMD increases occurred with long-term denosumab treatment (2.2% lumbar spine, 0.9% total hip, 1.3% femoral neck, 1.3% trochanter, and 0.2% 1/3 radius), resulting in cumulative 24-month gains from baseline of 8.0%, 3.4%, 3.4%, 4.6%, and 0.7%, respectively (all P < .01). The crossover group showed BMD gains after 12 months of denosumab treatment similar to those of the long-term denosumab group during the first treatment year. Significant reductions in serum collagen type I C-teleopeptide were observed after denosumab administration. Adverse event rates were similar between groups, and no new safety signals were identified.CONCLUSIONS: In men with low BMD, denosumab treatment for a second year continued to increase BMD, maintained reductions in bone resorption, and was well tolerated. BMD increased in men initiating denosumab during the second year. These effects were similar to those previously seen in postmenopausal women with osteoporosis and in men with prostate cancer receiving androgen deprivation therapy.

AB - CONTEXT: One in 4 men in the United States aged >50 years will have an osteoporosis-related fracture. Fewer data are available on osteoporosis treatment in men than in women.OBJECTIVE: The purpose of this study was to evaluate denosumab therapy in men with low bone mineral density (BMD).DESIGN: This was a phase 3 study with 2 treatment periods: a previously reported 12-month double-blind, placebo-controlled phase and a 12-month open-label phase.SETTING: This was a multicenter study conducted in North America and Europe.PARTICIPANTS: A total of 228 men entered the open-label phase and 219 completed the study.INTERVENTION: Men from the original denosumab (long-term) and placebo (crossover) groups received 60 mg of denosumab sc every 6 months.MAIN OUTCOME MEASURES: BMD, serum collagen type I C-telopeptide, and safety were measured.RESULTS: During the open-label phase, continued BMD increases occurred with long-term denosumab treatment (2.2% lumbar spine, 0.9% total hip, 1.3% femoral neck, 1.3% trochanter, and 0.2% 1/3 radius), resulting in cumulative 24-month gains from baseline of 8.0%, 3.4%, 3.4%, 4.6%, and 0.7%, respectively (all P < .01). The crossover group showed BMD gains after 12 months of denosumab treatment similar to those of the long-term denosumab group during the first treatment year. Significant reductions in serum collagen type I C-teleopeptide were observed after denosumab administration. Adverse event rates were similar between groups, and no new safety signals were identified.CONCLUSIONS: In men with low BMD, denosumab treatment for a second year continued to increase BMD, maintained reductions in bone resorption, and was well tolerated. BMD increased in men initiating denosumab during the second year. These effects were similar to those previously seen in postmenopausal women with osteoporosis and in men with prostate cancer receiving androgen deprivation therapy.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antibodies, Monoclonal, Humanized

KW - Biomarkers

KW - Bone Density

KW - Bone Density Conservation Agents

KW - Denosumab

KW - Femur Neck

KW - Fractures, Bone

KW - Humans

KW - Lumbar Vertebrae

KW - Male

KW - Middle Aged

KW - Osteoporosis

KW - Radius

KW - Treatment Outcome

U2 - 10.1210/jc.2014-4079

DO - 10.1210/jc.2014-4079

M3 - Journal article

C2 - 25607608

SN - 0021-972X

VL - 100

SP - 1335

EP - 1342

JO - The Journal of clinical endocrinology and metabolism

JF - The Journal of clinical endocrinology and metabolism

IS - 4

ER -

A 24-month study evaluating the efficacy and safety of denosumab for the treatment of men with low bone mineral density: results from the ADAMO trial

Abstract

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