Clinical trial NCT01575834: Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
Official title: A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Keywords: Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-04-12
Enrollment: 7180
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis


Eligibility criteria: Inclusion Criteria:

- Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)

Exclusion Criteria:

* BMD T-score of ≤ -3.50 at the total hip or femoral neck
* History of hip fracture
* Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays
* Use of agents affecting bone metabolism
* History of metabolic or bone disease (except osteoporosis)
* Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
* Current hyper- or hypocalcemia
* Current, uncontrolled hyper- or hypothyroidism
* Current, uncontrolled hyper- or hypoparathyroidism

Primary outcomes:
measure: Percentage of Participants With New Vertebral Fracture Through Month 12
timeFrame: 12 Months
measure: Percentage of Participants With New Vertebral Fracture Through Month 24
timeFrame: 24 months
Secondary outcomes:
measure: Percentage of Participants With a Clinical Fracture Through Month 12
timeFrame: 12 Months
measure: Percentage of Participants With a Nonvertebral Fracture Through Month 12
timeFrame: 12 Months
measure: Percentage of Participants With a Nonvertebral Fracture Through Month 24
timeFrame: 24 Months
measure: Percentage of Participants With a Clinical Fracture Through Month 24
timeFrame: 24 Months
measure: Percentage of Participants With a Major Nonvertebral Fracture Through Month 12
timeFrame: 12 Months
measure: Percentage of Participants With a Major Nonvertebral Fracture Through Month 24
timeFrame: 24 Months
measure: Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12
timeFrame: 12 Months
measure: Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24
timeFrame: 24 Months
measure: Percentage of Participants With a Hip Fracture Through Month 12
timeFrame: 12 Months
measure: Percentage of Participants With a Hip Fracture Through Month 24
timeFrame: 24 Months
measure: Percentage of Participants With a Major Osteoporotic Fracture Through Month 12
timeFrame: 12 Months
measure: Percentage of Participants With a Major Osteoporotic Fracture Through Month 24
timeFrame: 24 Months
measure: Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 12
timeFrame: 12 Months
measure: Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24
timeFrame: 24 Months
measure: Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12
timeFrame: Baseline and Month 12
measure: Percent Change From Baseline In Bone Mineral Density at the Lumbar Spine at Month 24
timeFrame: Baseline and Month 24
measure: Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 12
timeFrame: Baseline and Month 12
measure: Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24
timeFrame: Baseline and Month 24
measure: Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 12
timeFrame: Baseline and Month 12
measure: Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 24
timeFrame: Baseline and Month 24
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Laguna Hills
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Santa Maria
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Lakewood
country: United States
facility: Research Site
state: Colorado
city: Leesburg
country: United States
facility: Research Site
state: Florida
city: Palm Harbor
country: United States
facility: Research Site
state: Florida
city: Plantation
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Gainesville
country: United States
facility: Research Site
state: Georgia
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Mayfield
country: United States
facility: Research Site
state: Ohio
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Denton
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Research Site
state: Córdoba
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Maroubra
country: Australia
facility: Research Site
state: New South Wales
city: St Leonards
country: Australia
facility: Research Site
state: New South Wales
city: Herston
country: Australia
facility: Research Site
state: Queensland
city: Keswick
country: Australia
facility: Research Site
state: South Australia
city: Footscray
country: Australia
facility: Research Site
state: Victoria
city: Geelong
country: Australia
facility: Research Site
state: Victoria
city: Heidelberg West
country: Australia
facility: Research Site
state: Victoria
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Bruxelles
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Ghent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Lommel
country: Belgium
facility: Research Site
city: Yvoir
country: Belgium
facility: Research Site
city: Curitiba
country: Brazil
facility: Research Site
state: Paraná
city: Sao Paulo
country: Brazil
facility: Research Site
state: São Paulo
city: São Paulo
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Oakville
country: Canada
facility: Research Site
state: Ontario
city: Lachine
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Medellin
country: Colombia
facility: Research Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Research Site
state: Atlántico
city: Bogota
country: Colombia
facility: Research Site
state: Cundinamarca
city: Bogota
country: Colombia
facility: Research Site
state: Cundinamarca
city: Bogota
country: Colombia
facility: Research Site
state: Cundinamarca
city: Bogota
country: Colombia
facility: Research Site
state: Cundinamarca
city: Bogota
country: Colombia
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Ceske Budejovice
country: Czechia
facility: Research Site
city: Havlickuv Brod
country: Czechia
facility: Research Site
city: Klatovy
country: Czechia
facility: Research Site
city: Ostrava-Trebovice
country: Czechia
facility: Research Site
city: Pardubice
country: Czechia
facility: Research Site
city: Plzen
country: Czechia
facility: Research Site
city: Praha 11 - Chodov
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Praha 3
country: Czechia
facility: Research Site
city: Uherske Hradiste
country: Czechia
facility: Research Site
city: Zlin
country: Czechia
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Ballerup
country: Denmark
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: Odense
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Århus C
country: Denmark
facility: Research Site
city: Santo Domingo
country: Dominican Republic
facility: Research Site
state: Distrito Nacional
city: Santo Domingo
country: Dominican Republic
facility: Research Site
state: Distrito Nacional
city: Santo Domingo
country: Dominican Republic
facility: Research Site
city: Pärnu
country: Estonia
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Berlin (Hellersdorf)
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Görlitz
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heinsberg
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Schkeuditz
country: Germany
facility: Research Site
city: Bekescsaba
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Heviz
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Vellore
country: India
facility: Research Site
state: Tamil Nadu
city: Anjyo-shi
country: Japan
facility: Research Site
state: Aichi
city: Urayasu-shi
country: Japan
facility: Research Site
state: Chiba
city: Fukui-shi
country: Japan
facility: Research Site
state: Fukui
city: Fukui-shi
country: Japan
facility: Research Site
state: Fukui
city: Fukui-shi
country: Japan
facility: Research Site
state: Fukui
city: Fukui-shi
country: Japan
facility: Research Site
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Fukutsu-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Hiroshima-shi
country: Japan
facility: Research Site
state: Hiroshima
city: Chitose-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Ishikari-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Sunagawa-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Research Site
state: Hyogo
city: Kako-gun
country: Japan
facility: Research Site
state: Hyogo
city: Toride-shi
country: Japan
facility: Research Site
state: Ibaraki
city: Morioka-shi
country: Japan
facility: Research Site
state: Iwate
city: Takamatsu-shi
country: Japan
facility: Research Site
state: Kagawa
city: Kirishima-shi
country: Japan
facility: Research Site
state: Kagoshima
city: Minamikyusyu-shi
country: Japan
facility: Research Site
state: Kagoshima
city: Atugi-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Research Site
state: Kumamoto
city: Sendai-shi
country: Japan
facility: Research Site
state: Miyagi
city: Chiisagata-gun
country: Japan
facility: Research Site
state: Nagano
city: Matsumoto-shi
country: Japan
facility: Research Site
state: Nagano
city: Matsumoto-shi
country: Japan
facility: Research Site
state: Nagano
city: Ueda-shi
country: Japan
facility: Research Site
state: Nagano
city: Ueda-shi
country: Japan
facility: Research Site
state: Nagano
city: Bungoono-shi
country: Japan
facility: Research Site
state: Oita
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Research Site
state: Osaka
city: Saga-shi
country: Japan
facility: Research Site
state: Saga
city: Fujimi-shi
country: Japan
facility: Research Site
state: Saitama
city: Matsue-shi
country: Japan
facility: Research Site
state: Shimane
city: Fujinomiya-shi
country: Japan
facility: Research Site
state: Shizuoka
city: Kikugawa-shi
country: Japan
facility: Research Site
state: Shizuoka
city: Tokushima-Shi
country: Japan
facility: Research Site
state: Tokushima
city: Hachioji-shi
country: Japan
facility: Research Site
state: Tokyo
city: Kiyose-shi
country: Japan
facility: Research Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Research Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Research Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Suginami-ku
country: Japan
facility: Research Site
state: Tokyo
city: Suginami-ku
country: Japan
facility: Research Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Research Site
state: Tokyo
city: Kofu-shi
country: Japan
facility: Research Site
state: Yamanashi
city: Liepaja
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Klaipeda
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo León
city: Ciudad Obregon
country: Mexico
facility: Research Site
state: Sonora
city: Christchurch
country: New Zealand
facility: Research Site
city: Grafton, Auckland
country: New Zealand
facility: Research Site
city: Dabrowka Dopiewo
country: Poland
facility: Research Site
city: Elblag
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Swidnik
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Pozuelo de Alarcon
country: Spain
facility: Research Site
state: Madrid
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Fribourg
country: Switzerland
facility: Research Site
city: Genève 14
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Chorley
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 Oct 20;375(16):1532-1543. doi: 10.1056/NEJMoa1607948. Epub 2016 Sep 18.
citation: Cosman F, Crittenden DB, Ferrari S, Khan A, Lane NE, Lippuner K, Matsumoto T, Milmont CE, Libanati C, Grauer A. FRAME Study: The Foundation Effect of Building Bone With 1 Year of Romosozumab Leads to Continued Lower Fracture Risk After Transition to Denosumab. J Bone Miner Res. 2018 Jul;33(7):1219-1226. doi: 10.1002/jbmr.3427. Epub 2018 May 17.
citation: Chavassieux P, Chapurlat R, Portero-Muzy N, Roux JP, Garcia P, Brown JP, Libanati C, Boyce RW, Wang A, Grauer A. Bone-Forming and Antiresorptive Effects of Romosozumab in Postmenopausal Women With Osteoporosis: Bone Histomorphometry and Microcomputed Tomography Analysis After 2 and 12 Months of Treatment. J Bone Miner Res. 2019 Sep;34(9):1597-1608. doi: 10.1002/jbmr.3735. Epub 2019 Jun 24.
citation: Cosman F, Crittenden DB, Ferrari S, Lewiecki EM, Jaller-Raad J, Zerbini C, Milmont CE, Meisner PD, Libanati C, Grauer A. Romosozumab FRAME Study: A Post Hoc Analysis of the Role of Regional Background Fracture Risk on Nonvertebral Fracture Outcome. J Bone Miner Res. 2018 Aug;33(8):1407-1416. doi: 10.1002/jbmr.3439. Epub 2018 May 11.
citation: Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, Ebeling PR, Adachi JD, Miyauchi A, Gielen E, Milmont CE, Libanati C, Grauer A. One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study. J Bone Miner Res. 2019 Mar;34(3):419-428. doi: 10.1002/jbmr.3622. Epub 2018 Dec 3.
citation: Miyauchi A, Dinavahi RV, Crittenden DB, Yang W, Maddox JC, Hamaya E, Nakamura Y, Libanati C, Grauer A, Shimauchi J. Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension. Arch Osteoporos. 2019 Jun 5;14(1):59. doi: 10.1007/s11657-019-0608-z.
citation: Miyauchi A, Hamaya E, Yang W, Nishi K, Libanati C, Tolman C, Shimauchi J. Romosozumab followed by denosumab in Japanese women with high fracture risk in the FRAME trial. J Bone Miner Metab. 2021 Mar;39(2):278-288. doi: 10.1007/s00774-020-01147-5. Epub 2020 Oct 15.
citation: McCloskey EV, Johansson H, Harvey NC, Lorentzon M, Shi Y, Kanis JA. Romosozumab efficacy on fracture outcomes is greater in patients at high baseline fracture risk: a post hoc analysis of the first year of the frame study. Osteoporos Int. 2021 Aug;32(8):1601-1608. doi: 10.1007/s00198-020-05815-0. Epub 2021 Feb 3.
citation: Eriksen EF, Chapurlat R, Boyce RW, Shi Y, Brown JP, Horlait S, Betah D, Libanati C, Chavassieux P. Modeling-Based Bone Formation After 2 Months of Romosozumab Treatment: Results From the FRAME Clinical Trial. J Bone Miner Res. 2022 Jan;37(1):36-40. doi: 10.1002/jbmr.4457. Epub 2021 Nov 19.
citation: Miller PD, Adachi JD, Albergaria BH, Cheung AM, Chines AA, Gielen E, Langdahl BL, Miyauchi A, Oates M, Reid IR, Santiago NR, Vanderkelen M, Wang Z, Yu Z. Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease. J Bone Miner Res. 2022 Aug;37(8):1437-1445. doi: 10.1002/jbmr.4563. Epub 2022 May 20.
citation: Takada J, Dinavahi R, Miyauchi A, Hamaya E, Hirama T, Libanati C, Nakamura Y, Milmont CE, Grauer A. Relationship between P1NP, a biochemical marker of bone turnover, and bone mineral density in patients transitioned from alendronate to romosozumab or teriparatide: a post hoc analysis of the STRUCTURE trial. J Bone Miner Metab. 2020 May;38(3):310-315. doi: 10.1007/s00774-019-01057-1. Epub 2019 Nov 9.
citation: Miyauchi A, Hamaya E, Nishi K, Tolman C, Shimauchi J. Efficacy and safety of romosozumab among Japanese postmenopausal women with osteoporosis and mild-to-moderate chronic kidney disease. J Bone Miner Metab. 2022 Jul;40(4):677-687. doi: 10.1007/s00774-022-01332-8. Epub 2022 May 31.
citation: Eriksen EF, Boyce RW, Shi Y, Brown JP, Betah D, Libanati C, Oates M, Chapurlat R, Chavassieux P. Reconstruction of remodeling units reveals positive effects after 2 and 12 months of romosozumab treatment. J Bone Miner Res. 2024 Jul 23;39(6):729-736. doi: 10.1093/jbmr/zjae055.
citation: Lane NE, Betah D, Deignan C, Oates M, Wang Z, Timoshanko J, Khan AA, Binkley N. Effect of Romosozumab Treatment in Postmenopausal Women With Osteoporosis and Knee Osteoarthritis: Results From a Substudy of a Phase 3 Clinical Trial. ACR Open Rheumatol. 2024 Jan;6(1):43-51. doi: 10.1002/acr2.11619. Epub 2023 Nov 20.
citation: McClung MR, Betah D, Deignan C, Shi Y, Timoshanko J, Cosman F. Romosozumab Efficacy in Postmenopausal Women With No Prior Fracture Who Fulfill Criteria for Very High Fracture Risk. Endocr Pract. 2023 Sep;29(9):716-722. doi: 10.1016/j.eprac.2023.06.011. Epub 2023 Jul 4.
citation: Cosman F, Oates M, Betah D, Timoshanko J, Wang Z, Ferrari S, McClung MR. Romosozumab followed by denosumab versus denosumab only: a post hoc analysis of FRAME and FRAME extension. J Bone Miner Res. 2024 Sep 2;39(9):1268-1277. doi: 10.1093/jbmr/zjae116.