Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01631214
  4. Details
NCT01631214 Clinical Trial

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
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Completed NCT01249261 - Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover Phase 3
Active, not recruiting NCT05345691 - Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis Phase 3
Active, not recruiting NCT05338086 - A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study) Phase 3
Completed NCT04757376 - A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis Phase 3
Completed NCT03974100 - Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis Phase 3
Completed NCT01581320 - Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis Phase 3

External Links