Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Postmenopausal Women With Osteoporosis Clinical Trial

— ARCH  

Official title:

A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631214
• Other study ID #: 20110142
• Secondary ID: 2011-003142-41
• Status: Completed
• Phase: Phase 3
• Start date: May 4, 2012
• Est. completion date: June 29, 2017

Study information

• Verified date: November 2022
• 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 is effective in preventing fractures in women with postmenopausal osteoporosis.

Description:

In this trial, women were randomly assigned in a 1:1 ratio to receive monthly subcutaneous romosozumab or weekly oral alendronate for 12 months. Randomization was stratified according to age (<75 vs. ≥75 years). After completion of the double-blind treatment period, all the participants were to receive open-label weekly oral alendronate until the end of the trial, with blinding to the initial treatment assignment maintained.

The primary analysis was performed when clinical fracture events had been confirmed in at least 330 participants and all the participants had completed the month 24 visit. The study was to continue in an event-driven manner until at least 440 participants experienced a nonvertebral fracture or if the superiority of romosozumab was proven for nonvertebral fractures at the primary analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4093
• Est. completion date: June 29, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 90 Years

Eligibility

Inclusion Criteria:

Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria:

• BMD T-score at the total hip or femoral neck of = -2.50 and EITHER:

• at least 1 moderate (semiquantitative grade [SQ]2) or severe (SQ3) vertebral fracture OR

• at least 2 mild (SQ1) vertebral fractures OR

• BMD T-score at the total hip or femoral neck of = -2.00 and EITHER:

• at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR

• a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization.

Exclusion Criteria:

• History of metabolic or bone disease (except osteoporosis)

• Use of agents affecting bone metabolism

• Vitamin D insufficiency

• History of solid organ or bone marrow transplants

• Hyper- or hypocalcemia

• Hyper- or hypothyroidism

• Hyper- or hypoparathyroidism

• Possible signs of intolerance to alendronate

Related Conditions & MeSH terms

• Osteoporosis
• Postmenopausal Women With Osteoporosis

Intervention

Biological:
• Romosozumab
Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.

Drug:
• Alendronate
Alendronate 70 mg tablet taken once a week
• Placebo to Romosozumab
Administered by subcutaneous injection once a month during the double-blind treatment phase.
• Placebo to Alendronate
Matching placebo tablet taken once a week during the double-blind treatment phase.

Locations

Country	Name	City	State
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	Cordoba	Córdoba
Argentina	Research Site	Mar del Plata	Buenos Aires
Argentina	Research Site	Quilmes	Buenos Aires
Australia	Research Site	Box Hill	Victoria
Australia	Research Site	Darlinghurst	New South Wales
Australia	Research Site	Geelong	Victoria
Australia	Research Site	Heidelberg West	Victoria
Australia	Research Site	Kogarah	New South Wales
Australia	Research Site	Parkville	Victoria
Australia	Research Site	Randwick	New South Wales
Austria	Research Site	Graz
Austria	Research Site	Linz
Austria	Research Site	Wien
Belgium	Research Site	Brugge
Belgium	Research Site	Bruxelles
Belgium	Research Site	Genk
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Belgium	Research Site	Liège
Brazil	Research Site	Brasília	Distrito Federal
Brazil	Research Site	Curitiba	Paraná
Brazil	Research Site	Fortaleza	Ceará
Brazil	Research Site	Goiania	Goiás
Brazil	Research Site	Recife	Pernambuco
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	São Paulo
Brazil	Research Site	São Paulo
Brazil	Research Site	Vitória	Espírito Santo
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Kitchener	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Quebec
Canada	Research Site	St. Johns	Newfoundland and Labrador
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Trois-Rivieres	Quebec
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Westmout	Quebec
Canada	Research Site	Winnipeg	Manitoba
Chile	Research Site	Santiago
Colombia	Research Site	Barranquilla	Atlántico
Colombia	Research Site	Bogota	Cundinamarca
Colombia	Research Site	Bogota	Cundinamarca
Colombia	Research Site	Bogota	Cundinamarca
Colombia	Research Site	Bogota
Colombia	Research Site	Bucaramanga
Colombia	Research Site	Medellin	Antioquia
Czechia	Research Site	Brno
Czechia	Research Site	Hradec Kralove
Czechia	Research Site	Klatovy
Czechia	Research Site	Opava
Czechia	Research Site	Ostrava-Trebovice
Czechia	Research Site	Pardubice
Czechia	Research Site	Plzen
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	Koge
Denmark	Research Site	Odense
Denmark	Research Site	Vejle
Dominican Republic	Research Site	Santiago
Dominican Republic	Research Site	Santo Domingo
Dominican Republic	Research Site	Santo Domingo	Distrito Nacional
Dominican Republic	Research Site	Santo Domingo	Distrito Nacional
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
Finland	Research Site	Helsinki
Finland	Research Site	Jyväskylä
Finland	Research Site	Kuopio
Finland	Research Site	Turku
France	Research Site	Bordeaux Cedex
France	Research Site	Cahors Cedex
France	Research Site	Lille cedex
France	Research Site	Lyon Cédex 3
France	Research Site	Orleans Cedex
France	Research Site	Saint Priest en Jarez
France	Research Site	Toulouse Cedex 9
France	Research Site	Vandoeuvre les Nancy
Germany	Research Site	Berlin
Germany	Research Site	Berlin (Hellersdorf)
Germany	Research Site	Bonn
Germany	Research Site	Dresden
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Freiburg
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	München
Germany	Research Site	Würzburg
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Larissa
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Guatemala	Research Site	Antigua	Sacatepéquez
Guatemala	Research Site	Guatemala
Guatemala	Research Site	Guatemala
Guatemala	Research Site	Guatemala
Guatemala	Research Site	Guatemala
Guatemala	Research Site	Guatemala
Guatemala	Research Site	Guatemala
Guatemala	Research Site	Guatemala
Guatemala	Research Site	Guatemala
Hong Kong	Research Site	Hong Kong
Hong Kong	Research Site	New Territories
Hungary	Research Site	Balatonfured
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	Kaposvar
Hungary	Research Site	Kiskunhalas
Hungary	Research Site	Kistarcsa
Hungary	Research Site	Veszprem
Hungary	Research Site	Zalaegerszeg
Ireland	Research Site	Cork
Ireland	Research Site	Dublin
Ireland	Research Site	Galway
Israel	Research Site	Bnei Brak
Israel	Research Site	Haifa
Israel	Research Site	Jerusalem
Israel	Research Site	Jerusalem
Israel	Research Site	Tel Aviv
Italy	Research Site	Arenzano GE
Italy	Research Site	Bologna
Italy	Research Site	Catania
Italy	Research Site	Firenze
Italy	Research Site	Milan
Italy	Research Site	Pisa
Italy	Research Site	Pisa
Italy	Research Site	Roma
Italy	Research Site	Siena
Italy	Research Site	Torino
Italy	Research Site	Verona
Italy	Research Site	Verona
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Guri-si
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon-si, Gyeonggi-do
Latvia	Research Site	Liepaja
Latvia	Research Site	Riga
Latvia	Research Site	Riga
Lithuania	Research Site	Vilnius
Lithuania	Research Site	Vilnius
Mexico	Research Site	Ciudad Obregon	Sonora
Mexico	Research Site	Leon	Guanajuato
Mexico	Research Site	Leon	Guanajuato
Mexico	Research Site	Mexicali	Baja California Norte
Mexico	Research Site	Mexicalli	Baja California Norte
Mexico	Research Site	Mexico	Distrito Federal
Mexico	Research Site	Mexico	Distrito Federal
Mexico	Research Site	Monterrey	Nuevo León
Mexico	Research Site	Queretaro	Querétaro
Netherlands	Research Site	Leiden
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Venlo
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Grafton, Auckland
Norway	Research Site	Elverum
Norway	Research Site	Hamar
Norway	Research Site	Oslo
Norway	Research Site	Stavanger
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Poland	Research Site	Bialystok
Poland	Research Site	Bialystok
Poland	Research Site	Dabrowka Dopiewo
Poland	Research Site	Elblag
Poland	Research Site	Gdynia
Poland	Research Site	Gliwice
Poland	Research Site	Katowice
Poland	Research Site	Kielce
Poland	Research Site	Krakow
Poland	Research Site	Kraków
Poland	Research Site	Lodz
Poland	Research Site	Lodz
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Swidnik
Poland	Research Site	Torun
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Oradea
Romania	Research Site	Targu Mures
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Ivanovo
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhniy Novgorod
Russian Federation	Research Site	Petrozavodsk
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Yaroslavl
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Kosice-Saca
Slovakia	Research Site	Lucenec
Slovakia	Research Site	Piestany
Slovakia	Research Site	Trencin
South Africa	Research Site	Johannesburg	Gauteng
South Africa	Research Site	Parow	Western Cape
South Africa	Research Site	Pretoria	Gauteng
South Africa	Research Site	Pretoria	Gauteng
South Africa	Research Site	Somerset West	Western Cape
South Africa	Research Site	Tygerberg
Spain	Research Site	A Coruña	Galicia
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Granada	Andalucía
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Sant Joan Despi	Cataluña
Spain	Research Site	Santander	Cantabria
Spain	Research Site	Sevilla	Andalucía
Sweden	Research Site	Linköping
Sweden	Research Site	Mölndal
Sweden	Research Site	Stockholm
Sweden	Research Site	Umeå
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Turkey	Research Site	Adana
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Chorley
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Northwood
United Kingdom	Research Site	Norwich
United Kingdom	Research Site	Reading
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Sidcup
United Kingdom	Research Site	Staffordshire
United Kingdom	Research Site	Warwick
United States	Research Site	Bethesda	Maryland
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bismarck	North Dakota
United States	Research Site	Boston	Massachusetts
United States	Research Site	Detroit	Michigan
United States	Research Site	Downey	California
United States	Research Site	Fort Lauderdale	Florida
United States	Research Site	Gainesville	Georgia
United States	Research Site	Great Neck	New York
United States	Research Site	Greenbrae	California
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Lakewood	Colorado
United States	Research Site	Las Cruces	New Mexico
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Los Angeles	California
United States	Research Site	Madison	Wisconsin
United States	Research Site	Maywood	Illinois
United States	Research Site	Miami	Florida
United States	Research Site	Peoria	Arizona
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Port Angeles	Washington
United States	Research Site	Quincy	Illinois
United States	Research Site	Richmond	Virginia
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Scottsdale	Arizona
United States	Research Site	South Lake Tahoe	California
United States	Research Site	Stuart	Florida
United States	Research Site	Tustin	California
United States	Research Site	Walnut Creek	California
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Czechia,  Denmark,  Dominican Republic,  Estonia,  Finland,  France,  Germany,  Greece,  Guatemala,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  New Zealand,  Norway,  Peru,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

References & Publications (1)

Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With New Vertebral Fractures Through Month 24	All fracture assessments were performed by blinded central imaging readers.; 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 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.; Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method.	24 months
Primary	Percentage of Participants With a Clinical Fracture at the Primary Analysis	All fracture assessments were performed by blinded central imaging readers. 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.	The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Secondary	Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis	A nonvertebral fracture was defined as a documented fracture 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.	The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Secondary	Percentage of Participants With Any Fracture at the Primary Analysis	All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures.	The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
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 according to the Genant Semiquantitative Scoring method 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.; Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method.	24 months
Secondary	Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis	Major nonvertebral fractures included 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.	The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Secondary	Percentage of Participants With a Hip Fracture at the Primary Analysis	Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.	The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
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 according to the Genant Semiquantitative Scoring method. 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. Incident vertebral fractures were confirmed by a second independent reader.	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 Nonvertebral Fracture Through Month 24	A nonvertebral fracture was defined as a documented fracture 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 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 Clinical Vertebral Fracture Through Month 24	A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic.	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 New Vertebral Fractures 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 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.; Incident vertebral fractures were confirmed by a second independent reader.	12 months
Secondary	Percentage of Participants With Any Fracture Through Month 12	All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures.	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 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 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 Clinical Vertebral Fracture Through Month 12	A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic.	12 months
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 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 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 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 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 at 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 Lumbar Spine at Month 36	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 36
Secondary	Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36	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 36
Secondary	Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36	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 36

External Links

•   AmgenTrials clinical trials website