A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
NCT ID: NCT00089791
Last Updated: 2022-11-08
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
7808 participants
Study Classification
INTERVENTIONAL
Study Start Date
2004-08-01
Study Completion Date
2008-06-17
Brief Summary
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This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.
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Detailed Description
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Conditions
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Osteoporosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Placebo
Placebo administered subcutaneously once every 6 months for 3 years.
Group Type
PLACEBO_COMPARATOR
placebo
Intervention Type
DRUG
Placebo administered by subcutaneous injection
Denosumab 60 mg Q6M
Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
Group Type
EXPERIMENTAL
Denosumab
Intervention Type
DRUG
Denosumab 60 mg administered by subcutaneous injection
Interventions
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placebo
Placebo administered by subcutaneous injection
Intervention Type
DRUG
Denosumab
Denosumab 60 mg administered by subcutaneous injection
Intervention Type
DRUG
Other Intervention Names
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AMG 162
Prolia®
Eligibility Criteria
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Inclusion Criteria
* Women who are 60 to 90 years of age may be eligible to participate
* Bone mineral density (BMD) T-Score at hip or spine must be less than -2.5
* Bone mineral density (BMD) T-Score at hip or spine must be less than -2.5
Exclusion Criteria
* BMD T-Score at the hip or the spine of less than -4.0
* Patients with any severe or more than two moderate vertebral fractures on spinal x-ray at entry
* Patients with any severe or more than two moderate vertebral fractures on spinal x-ray at entry
Minimum Eligible Age
60 Years
Maximum Eligible Age
90 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Amgen
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
References
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Adami S, Libanati C, Boonen S, Cummings SR, Ho PR, Wang A, Siris E, Lane J; FREEDOM Fracture-Healing Writing Group; Adachi JD, Bhandari M, de Gregorio L, Gilchrist N, Lyritis G, Moller G, Palacios S, Pavelka K, Heinrich R, Roux C, Uebelhart D. Denosumab treatment in postmenopausal women with osteoporosis does not interfere with fracture-healing: results from the FREEDOM trial. J Bone Joint Surg Am. 2012 Dec 5;94(23):2113-9. doi: 10.2106/JBJS.K.00774.
Reference Type
BACKGROUND
Austin M, Yang YC, Vittinghoff E, Adami S, Boonen S, Bauer DC, Bianchi G, Bolognese MA, Christiansen C, Eastell R, Grauer A, Hawkins F, Kendler DL, Oliveri B, McClung MR, Reid IR, Siris ES, Zanchetta J, Zerbini CA, Libanati C, Cummings SR; FREEDOM Trial. Relationship between bone mineral density changes with denosumab treatment and risk reduction for vertebral and nonvertebral fractures. J Bone Miner Res. 2012 Mar;27(3):687-93. doi: 10.1002/jbmr.1472.
Reference Type
BACKGROUND
Bolognese MA, Teglbjaerg CS, Zanchetta JR, Lippuner K, McClung MR, Brandi ML, Hoiseth A, Lakatos P, Moffett AH, Lorenc RS, Wang A, Libanati C. Denosumab significantly increases DXA BMD at both trabecular and cortical sites: results from the FREEDOM study. J Clin Densitom. 2013 Apr-Jun;16(2):147-53. doi: 10.1016/j.jocd.2012.02.006. Epub 2012 Apr 20.
Reference Type
BACKGROUND
Boonen S, Adachi JD, Man Z, Cummings SR, Lippuner K, Torring O, Gallagher JC, Farrerons J, Wang A, Franchimont N, San Martin J, Grauer A, McClung M. Treatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high risk. J Clin Endocrinol Metab. 2011 Jun;96(6):1727-36. doi: 10.1210/jc.2010-2784. Epub 2011 Mar 16.
Reference Type
BACKGROUND
Brown JP, Roux C, Torring O, Ho PR, Beck Jensen JE, Gilchrist N, Recknor C, Austin M, Wang A, Grauer A, Wagman RB. Discontinuation of denosumab and associated fracture incidence: analysis from the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) trial. J Bone Miner Res. 2013 Apr;28(4):746-52. doi: 10.1002/jbmr.1808.
Reference Type
BACKGROUND
Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 Aug 20;361(8):756-65. doi: 10.1056/NEJMoa0809493. Epub 2009 Aug 11.
Reference Type
BACKGROUND
Eastell R, Christiansen C, Grauer A, Kutilek S, Libanati C, McClung MR, Reid IR, Resch H, Siris E, Uebelhart D, Wang A, Weryha G, Cummings SR. Effects of denosumab on bone turnover markers in postmenopausal osteoporosis. J Bone Miner Res. 2011 Mar;26(3):530-7. doi: 10.1002/jbmr.251.
Reference Type
BACKGROUND
Freemantle N, Cooper C, Diez-Perez A, Gitlin M, Radcliffe H, Shepherd S, Roux C. Results of indirect and mixed treatment comparison of fracture efficacy for osteoporosis treatments: a meta-analysis. Osteoporos Int. 2013 Jan;24(1):209-17. doi: 10.1007/s00198-012-2068-9. Epub 2012 Jul 26.
Reference Type
BACKGROUND
Genant HK, Libanati C, Engelke K, Zanchetta JR, Hoiseth A, Yuen CK, Stonkus S, Bolognese MA, Franek E, Fuerst T, Radcliffe HS, McClung MR. Improvements in hip trabecular, subcortical, and cortical density and mass in postmenopausal women with osteoporosis treated with denosumab. Bone. 2013 Oct;56(2):482-8. doi: 10.1016/j.bone.2013.07.011. Epub 2013 Jul 17.
Reference Type
BACKGROUND
Hadji P, Bock O, Resch H, Kraenzlin M, Wang A, Steinle T, Eisen C. Reduction of fracture risk with denosumab among women with osteoporosis with or without need for treatment according to DVO 2009 guideline : A subgroup analysis of the FREEDOM trial. Osteologie. 2013;22(1):39-45.
Reference Type
BACKGROUND
Jamal SA, Ljunggren O, Stehman-Breen C, Cummings SR, McClung MR, Goemaere S, Ebeling PR, Franek E, Yang YC, Egbuna OI, Boonen S, Miller PD. Effects of denosumab on fracture and bone mineral density by level of kidney function. J Bone Miner Res. 2011 Aug;26(8):1829-35. doi: 10.1002/jbmr.403.
Reference Type
BACKGROUND
Keaveny TM, McClung MR, Genant HK, Zanchetta JR, Kendler D, Brown JP, Goemaere S, Recknor C, Brandi ML, Eastell R, Kopperdahl DL, Engelke K, Fuerst T, Radcliffe HS, Libanati C. Femoral and vertebral strength improvements in postmenopausal women with osteoporosis treated with denosumab. J Bone Miner Res. 2014 Jan;29(1):158-65. doi: 10.1002/jbmr.2024.
Reference Type
BACKGROUND
Mackey DC, Black DM, Bauer DC, McCloskey EV, Eastell R, Mesenbrink P, Thompson JR, Cummings SR. Effects of antiresorptive treatment on nonvertebral fracture outcomes. J Bone Miner Res. 2011 Oct;26(10):2411-8. doi: 10.1002/jbmr.446.
Reference Type
BACKGROUND
McCloskey EV, Johansson H, Oden A, Austin M, Siris E, Wang A, Lewiecki EM, Lorenc R, Libanati C, Kanis JA. Denosumab reduces the risk of osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX. J Bone Miner Res. 2012 Jul;27(7):1480-6. doi: 10.1002/jbmr.1606.
Reference Type
BACKGROUND
McClung MR, Boonen S, Torring O, Roux C, Rizzoli R, Bone HG, Benhamou CL, Lems WF, Minisola S, Halse J, Hoeck HC, Eastell R, Wang A, Siddhanti S, Cummings SR. Effect of denosumab treatment on the risk of fractures in subgroups of women with postmenopausal osteoporosis. J Bone Miner Res. 2012 Jan;27(1):211-8. doi: 10.1002/jbmr.536.
Reference Type
BACKGROUND
McClung MR, Zanchetta JR, Hoiseth A, Kendler DL, Yuen CK, Brown JP, Stonkus S, Goemaere S, Recknor C, Woodson GC, Bolognese MA, Franek E, Brandi ML, Wang A, Libanati C. Denosumab densitometric changes assessed by quantitative computed tomography at the spine and hip in postmenopausal women with osteoporosis. J Clin Densitom. 2013 Apr-Jun;16(2):250-6. doi: 10.1016/j.jocd.2012.02.014. Epub 2012 May 8.
Reference Type
BACKGROUND
Samelson EJ, Miller PD, Christiansen C, Daizadeh NS, Grazette L, Anthony MS, Egbuna O, Wang A, Siddhanti SR, Cheung AM, Franchimont N, Kiel DP. RANKL inhibition with denosumab does not influence 3-year progression of aortic calcification or incidence of adverse cardiovascular events in postmenopausal women with osteoporosis and high cardiovascular risk. J Bone Miner Res. 2014 Feb;29(2):450-7. doi: 10.1002/jbmr.2043.
Reference Type
BACKGROUND
Silverman S, Viswanathan HN, Yang YC, Wang A, Boonen S, Ragi-Eis S, Fardellone P, Gilchrist N, Lips P, Nevitt M, Palacios Gil-Antunano S, Pavelka K, Revicki D, Simon J, Macarios D, Siris ES. Impact of clinical fractures on health-related quality of life is dependent on time of assessment since fracture: results from the FREEDOM trial. Osteoporos Int. 2012 Apr;23(4):1361-9. doi: 10.1007/s00198-011-1720-0. Epub 2011 Jul 19.
Reference Type
BACKGROUND
Simon JA, Recknor C, Moffett AH Jr, Adachi JD, Franek E, Lewiecki EM, McClung MR, Mautalen CA, Ragi-Eis S, Nicholson GC, Muschitz C, Nuti R, Torring O, Wang A, Libanati C. Impact of denosumab on the peripheral skeleton of postmenopausal women with osteoporosis: bone density, mass, and strength of the radius, and wrist fracture. Menopause. 2013 Feb;20(2):130-7. doi: 10.1097/gme.0b013e318267f909.
Reference Type
BACKGROUND
Strom O, Jonsson B, Kanis JA. Intervention thresholds for denosumab in the UK using a FRAX(R)-based cost-effectiveness analysis. Osteoporos Int. 2013 Apr;24(4):1491-502. doi: 10.1007/s00198-012-2115-6. Epub 2012 Dec 7.
Reference Type
BACKGROUND
Watts NB, Roux C, Modlin JF, Brown JP, Daniels A, Jackson S, Smith S, Zack DJ, Zhou L, Grauer A, Ferrari S. Infections in postmenopausal women with osteoporosis treated with denosumab or placebo: coincidence or causal association? Osteoporos Int. 2012 Jan;23(1):327-37. doi: 10.1007/s00198-011-1755-2. Epub 2011 Sep 3.
Reference Type
BACKGROUND
Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.
Reference Type
DERIVED
Broadwell A, Chines A, Ebeling PR, Franek E, Huang S, Smith S, Kendler D, Messina O, Miller PD. Denosumab Safety and Efficacy Among Participants in the FREEDOM Extension Study With Mild to Moderate Chronic Kidney Disease. J Clin Endocrinol Metab. 2021 Jan 23;106(2):397-409. doi: 10.1210/clinem/dgaa851.
Reference Type
DERIVED
Ferrari S, Lewiecki EM, Butler PW, Kendler DL, Napoli N, Huang S, Crittenden DB, Pannacciulli N, Siris E, Binkley N. Favorable skeletal benefit/risk of long-term denosumab therapy: A virtual-twin analysis of fractures prevented relative to skeletal safety events observed. Bone. 2020 May;134:115287. doi: 10.1016/j.bone.2020.115287. Epub 2020 Feb 21.
Reference Type
DERIVED
Ferrari S, Eastell R, Napoli N, Schwartz A, Hofbauer LC, Chines A, Wang A, Pannacciulli N, Cummings SR. Denosumab in postmenopausal women with osteoporosis and diabetes: Subgroup analysis of FREEDOM and FREEDOM extension. Bone. 2020 May;134:115268. doi: 10.1016/j.bone.2020.115268. Epub 2020 Feb 10.
Reference Type
DERIVED
Ferrari S, Butler PW, Kendler DL, Miller PD, Roux C, Wang AT, Huang S, Wagman RB, Lewiecki EM. Further Nonvertebral Fracture Reduction Beyond 3 Years for Up to 10 Years of Denosumab Treatment. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3450-3461. doi: 10.1210/jc.2019-00271.
Reference Type
DERIVED
Watts NB, Grbic JT, Binkley N, Papapoulos S, Butler PW, Yin X, Tierney A, Wagman RB, McClung M. Invasive Oral Procedures and Events in Postmenopausal Women With Osteoporosis Treated With Denosumab for Up to 10 Years. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2443-2452. doi: 10.1210/jc.2018-01965.
Reference Type
DERIVED
Dempster DW, Brown JP, Fahrleitner-Pammer A, Kendler D, Rizzo S, Valter I, Wagman RB, Yin X, Yue SV, Boivin G. Effects of Long-Term Denosumab on Bone Histomorphometry and Mineralization in Women With Postmenopausal Osteoporosis. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2498-2509. doi: 10.1210/jc.2017-02669.
Reference Type
DERIVED
Napoli N, Pannacciulli N, Vittinghoff E, Crittenden D, Yun J, Wang A, Wagman R, Schwartz AV. Effect of denosumab on fasting glucose in women with diabetes or prediabetes from the FREEDOM trial. Diabetes Metab Res Rev. 2018 May;34(4):e2991. doi: 10.1002/dmrr.2991. Epub 2018 Apr 16.
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DERIVED
Cummings SR, Ferrari S, Eastell R, Gilchrist N, Jensen JB, McClung M, Roux C, Torring O, Valter I, Wang AT, Brown JP. Vertebral Fractures After Discontinuation of Denosumab: A Post Hoc Analysis of the Randomized Placebo-Controlled FREEDOM Trial and Its Extension. J Bone Miner Res. 2018 Feb;33(2):190-198. doi: 10.1002/jbmr.3337. Epub 2017 Nov 22.
Reference Type
DERIVED
Bone HG, Wagman RB, Brandi ML, Brown JP, Chapurlat R, Cummings SR, Czerwinski E, Fahrleitner-Pammer A, Kendler DL, Lippuner K, Reginster JY, Roux C, Malouf J, Bradley MN, Daizadeh NS, Wang A, Dakin P, Pannacciulli N, Dempster DW, Papapoulos S. 10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension. Lancet Diabetes Endocrinol. 2017 Jul;5(7):513-523. doi: 10.1016/S2213-8587(17)30138-9. Epub 2017 May 22.
Reference Type
DERIVED
Zebaze R, Libanati C, McClung MR, Zanchetta JR, Kendler DL, Hoiseth A, Wang A, Ghasem-Zadeh A, Seeman E. Denosumab Reduces Cortical Porosity of the Proximal Femoral Shaft in Postmenopausal Women With Osteoporosis. J Bone Miner Res. 2016 Oct;31(10):1827-1834. doi: 10.1002/jbmr.2855. Epub 2016 May 19.
Reference Type
DERIVED
Reid IR, Miller PD, Brown JP, Kendler DL, Fahrleitner-Pammer A, Valter I, Maasalu K, Bolognese MA, Woodson G, Bone H, Ding B, Wagman RB, San Martin J, Ominsky MS, Dempster DW; Denosumab Phase 3 Bone Histology Study Group. Effects of denosumab on bone histomorphometry: the FREEDOM and STAND studies. J Bone Miner Res. 2010 Oct;25(10):2256-65. doi: 10.1002/jbmr.149.
Reference Type
DERIVED
Related Links
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http://www.amgentrials.com
AmgenTrials clinical trials website
Other Identifiers
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20030216
Identifier Type: -
Identifier Source: org_study_id
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