Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

Postmenopausal Osteoporosis Clinical Trial

— FRAME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575834
• Other study ID #: 20070337
• Secondary ID: 2011-001456-11
• Status: Completed
• Phase: Phase 3
• Start date: March 15, 2012
• Est. completion date: December 28, 2016

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7180
• Est. completion date: December 28, 2016
• Est. primary completion date: December 14, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• Romosozumab
Administered by subcutaneous injection once a month (QM)
• Placebo
Administered by subcutaneous injection once a month (QM)
• Denosumab
Administered by subcutaneous injection once every 6 months (Q6M)

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Cordoba	Córdoba
Argentina	Research Site	Mar del Plata	Buenos Aires
Australia	Research Site	Footscray	Victoria
Australia	Research Site	Geelong	Victoria
Australia	Research Site	Heidelberg West	Victoria
Australia	Research Site	Herston	Queensland
Australia	Research Site	Keswick	South Australia
Australia	Research Site	Maroubra	New South Wales
Australia	Research Site	Nedlands	Western Australia
Australia	Research Site	St Leonards	New South Wales
Belgium	Research Site	Bruxelles
Belgium	Research Site	Genk
Belgium	Research Site	Ghent
Belgium	Research Site	Leuven
Belgium	Research Site	Liège
Belgium	Research Site	Lommel
Belgium	Research Site	Yvoir
Brazil	Research Site	Curitiba	Paraná
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	São Paulo
Brazil	Research Site	São Paulo
Brazil	Research Site	São Paulo
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Lachine	Quebec
Canada	Research Site	Oakville	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Vancouver	British Columbia
Colombia	Research Site	Barranquilla	Atlántico
Colombia	Research Site	Bogota	Cundinamarca
Colombia	Research Site	Bogota	Cundinamarca
Colombia	Research Site	Bogota	Cundinamarca
Colombia	Research Site	Bogota	Cundinamarca
Colombia	Research Site	Bogota
Colombia	Research Site	Medellin	Antioquia
Czechia	Research Site	Brno
Czechia	Research Site	Ceske Budejovice
Czechia	Research Site	Havlickuv Brod
Czechia	Research Site	Klatovy
Czechia	Research Site	Ostrava-Trebovice
Czechia	Research Site	Pardubice
Czechia	Research Site	Plzen
Czechia	Research Site	Praha 11 - Chodov
Czechia	Research Site	Praha 2
Czechia	Research Site	Praha 3
Czechia	Research Site	Uherske Hradiste
Czechia	Research Site	Zlin
Denmark	Research Site	Aalborg
Denmark	Research Site	Århus C
Denmark	Research Site	Ballerup
Denmark	Research Site	Glostrup
Denmark	Research Site	Hvidovre
Denmark	Research Site	Odense
Denmark	Research Site	Vejle
Dominican Republic	Research Site	Santo Domingo	Distrito Nacional
Dominican Republic	Research Site	Santo Domingo	Distrito Nacional
Dominican Republic	Research Site	Santo Domingo
Estonia	Research Site	Pärnu
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
Germany	Research Site	Berlin
Germany	Research Site	Berlin (Hellersdorf)
Germany	Research Site	Bochum
Germany	Research Site	Dresden
Germany	Research Site	Dresden
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Görlitz
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Heinsberg
Germany	Research Site	Leipzig
Germany	Research Site	Magdeburg
Germany	Research Site	Marburg
Germany	Research Site	Schkeuditz
Hungary	Research Site	Bekescsaba
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyor
Hungary	Research Site	Heviz
Hungary	Research Site	Szeged
Hungary	Research Site	Zalaegerszeg
India	Research Site	Bangalore	Karnataka
India	Research Site	Chennai	Tamil Nadu
India	Research Site	Jaipur	Rajasthan
India	Research Site	Mumbai	Maharashtra
India	Research Site	Pune	Maharashtra
India	Research Site	Vellore	Tamil Nadu
Japan	Research Site	Akashi-shi	Hyogo
Japan	Research Site	Anjyo-shi	Aichi
Japan	Research Site	Atugi-shi	Kanagawa
Japan	Research Site	Bungoono-shi	Oita
Japan	Research Site	Chiisagata-gun	Nagano
Japan	Research Site	Chitose-shi	Hokkaido
Japan	Research Site	Fujimi-shi	Saitama
Japan	Research Site	Fujinomiya-shi	Shizuoka
Japan	Research Site	Fukui-shi	Fukui
Japan	Research Site	Fukui-shi	Fukui
Japan	Research Site	Fukui-shi	Fukui
Japan	Research Site	Fukui-shi	Fukui
Japan	Research Site	Fukuoka-shi	Fukuoka
Japan	Research Site	Fukutsu-shi	Fukuoka
Japan	Research Site	Hachioji-shi	Tokyo
Japan	Research Site	Hiroshima-shi	Hiroshima
Japan	Research Site	Ishikari-shi	Hokkaido
Japan	Research Site	Kako-gun	Hyogo
Japan	Research Site	Kikugawa-shi	Shizuoka
Japan	Research Site	Kirishima-shi	Kagoshima
Japan	Research Site	Kitakyushu-shi	Fukuoka
Japan	Research Site	Kiyose-shi	Tokyo
Japan	Research Site	Kofu-shi	Yamanashi
Japan	Research Site	Kumamoto-shi	Kumamoto
Japan	Research Site	Kurume-shi	Fukuoka
Japan	Research Site	Kurume-shi	Fukuoka
Japan	Research Site	Matsue-shi	Shimane
Japan	Research Site	Matsumoto-shi	Nagano
Japan	Research Site	Matsumoto-shi	Nagano
Japan	Research Site	Minamikyusyu-shi	Kagoshima
Japan	Research Site	Minato-ku	Tokyo
Japan	Research Site	Morioka-shi	Iwate
Japan	Research Site	Osaka-shi	Osaka
Japan	Research Site	Ota-ku	Tokyo
Japan	Research Site	Saga-shi	Saga
Japan	Research Site	Sagamihara-shi	Kanagawa
Japan	Research Site	Sendai-shi	Miyagi
Japan	Research Site	Setagaya-ku	Tokyo
Japan	Research Site	Shinagawa-ku	Tokyo
Japan	Research Site	Shinagawa-ku	Tokyo
Japan	Research Site	Suginami-ku	Tokyo
Japan	Research Site	Suginami-ku	Tokyo
Japan	Research Site	Sunagawa-shi	Hokkaido
Japan	Research Site	Takamatsu-shi	Kagawa
Japan	Research Site	Takatsuki-shi	Osaka
Japan	Research Site	Tokushima-Shi	Tokushima
Japan	Research Site	Toride-shi	Ibaraki
Japan	Research Site	Toshima-ku	Tokyo
Japan	Research Site	Ueda-shi	Nagano
Japan	Research Site	Ueda-shi	Nagano
Japan	Research Site	Urayasu-shi	Chiba
Japan	Research Site	Yokohama-shi	Kanagawa
Japan	Research Site	Yokohama-shi	Kanagawa
Japan	Research Site	Yokohama-shi	Kanagawa
Japan	Research Site	Yokohama-shi	Kanagawa
Japan	Research Site	Yokohama-shi	Kanagawa
Latvia	Research Site	Liepaja
Latvia	Research Site	Riga
Latvia	Research Site	Riga
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Klaipeda
Lithuania	Research Site	Vilnius
Lithuania	Research Site	Vilnius
Mexico	Research Site	Ciudad Obregon	Sonora
Mexico	Research Site	Mexico	Distrito Federal
Mexico	Research Site	Monterrey	Nuevo León
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Grafton, Auckland
Poland	Research Site	Dabrowka Dopiewo
Poland	Research Site	Elblag
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Swidnik
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Romania	Research Site	Bucharest
Romania	Research Site	Bucuresti
Romania	Research Site	Timisoara
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Pozuelo de Alarcon	Madrid
Spain	Research Site	Valencia	Comunidad Valenciana
Switzerland	Research Site	Bern
Switzerland	Research Site	Fribourg
Switzerland	Research Site	Genève 14
Switzerland	Research Site	Lausanne
Switzerland	Research Site	Zurich
Switzerland	Research Site	Zurich
United Kingdom	Research Site	Chorley
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Northwood
United Kingdom	Research Site	Reading
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Asheville	North Carolina
United States	Research Site	Bethesda	Maryland
United States	Research Site	Boston	Massachusetts
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Denton	Texas
United States	Research Site	Detroit	Michigan
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Fargo	North Dakota
United States	Research Site	Gainesville	Georgia
United States	Research Site	Laguna Hills	California
United States	Research Site	Lakewood	Colorado
United States	Research Site	Leesburg	Florida
United States	Research Site	Los Angeles	California
United States	Research Site	Madison	Wisconsin
United States	Research Site	Mayfield	Ohio
United States	Research Site	New Orleans	Louisiana
United States	Research Site	Palm Harbor	Florida
United States	Research Site	Plantation	Florida
United States	Research Site	Richmond	Virginia
United States	Research Site	Sacramento	California
United States	Research Site	Santa Maria	California
United States	Research Site	Tampa	Florida
United States	Research Site	Tucson	Arizona
United States	Research Site	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Colombia,  Czechia,  Denmark,  Dominican Republic,  Estonia,  Germany,  Hungary,  India,  Japan,  Latvia,  Lithuania,  Mexico,  New Zealand,  Poland,  Romania,  Spain,  Switzerland,  United Kingdom, 

References & Publications (15)

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. — View 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. — View 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. — View 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. — View 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 Apr 19:zjae055. doi: 10.1093/jbmr/zjae055. Online ahead of print. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: J Bone Miner Metab. 2020 Mar 20;: — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With New Vertebral Fracture Through Month 12	New vertebral fractures occurred when there was = 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method.; The Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale: Grade 0 (Normal) = no fracture; Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.	12 Months
Primary	Percentage of Participants With New Vertebral Fracture Through Month 24	New vertebral fractures occurred when there was = 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method.; The Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale: Grade 0 (Normal) = no fracture; Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.	24 months
Secondary	Percentage of Participants With a Clinical Fracture Through Month 12	Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.	12 Months
Secondary	Percentage of Participants With a Nonvertebral Fracture Through Month 12	A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.	12 Months
Secondary	Percentage of Participants With a Nonvertebral Fracture Through Month 24	A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date as recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.	24 Months
Secondary	Percentage of Participants With a Clinical Fracture Through Month 24	Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.	24 Months
Secondary	Percentage of Participants With a Major Nonvertebral Fracture Through Month 12	A major nonvertebral fracture was a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.	12 Months
Secondary	Percentage of Participants With a Major Nonvertebral Fracture Through Month 24	A major nonvertebral fracture was a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.	24 Months
Secondary	Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12	A new or worsening vertebral fracture was identified when there was a = 1 grade increase from the previous grade in any vertebra from T4 to L4.	12 Months
Secondary	Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24	A new or worsening vertebral fracture was identified when there was a = 1 grade increase from the previous grade in any vertebra from T4 to L4.	24 Months
Secondary	Percentage of Participants With a Hip Fracture Through Month 12	Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.	12 Months
Secondary	Percentage of Participants With a Hip Fracture Through Month 24	Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.	24 Months
Secondary	Percentage of Participants With a Major Osteoporotic Fracture Through Month 12	Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.	12 Months
Secondary	Percentage of Participants With a Major Osteoporotic Fracture Through Month 24	Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.	24 Months
Secondary	Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 12	A new or worsening vertebral fracture was identified when there was a = 1 grade increase from the previous grade in any vertebra from T4 to L4. A participant had multiple new or worsening vertebral fractures when there were = 2 vertebrae from T4 to L4 with = 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit.	12 Months
Secondary	Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24	A new or worsening vertebral fracture was identified when there was a = 1 grade increase from the previous grade in any vertebra from T4 to L4. A participant had multiple new or worsening vertebral fractures when there were = 2 vertebrae from T4 to L4 with = 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit.	24 Months
Secondary	Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12	Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.	Baseline and Month 12
Secondary	Percent Change From Baseline In Bone Mineral Density at the Lumbar Spine at Month 24	Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.	Baseline and Month 24
Secondary	Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 12	Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.	Baseline and Month 12
Secondary	Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24	Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.	Baseline and Month 24
Secondary	Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 12	Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.	Baseline and Month 12
Secondary	Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 24	Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.	Baseline and Month 24

External Links

•   AmgenTrials clinical trials website