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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01631214
First received: May 24, 2012
Last updated: April 9, 2015
Last verified: April 2015
  Purpose

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


Condition Intervention Phase
Postmenopausal Women With Osteoporosis
Drug: Romosozumab
Drug: Alendronate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Incidence of clinical fracture [ Time Frame: From baseline until the date of first clinical fracture assessed (approximately 24 months) ] [ Designated as safety issue: No ]
    Event driven

  • Incidence of new vertebral fracture [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of fracture [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent changes in DXA Bone Mineral Density from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of fracture [ Time Frame: From baseline until the date of first clinical fracture assessed (approximately 24 months) ] [ Designated as safety issue: No ]
    Event driven

  • Percent changes in DXA Bone Mineral Density from baseline to 24 months [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Percent changes in DXA Bone Mineral Density from baseline to 36 months [ Time Frame: 36 Months ] [ Designated as safety issue: No ]

Enrollment: 4094
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Romosozumab
Romosozumab sub-cutaneous injections and placebo alendronate (oral) for 12 months, followed by open-label alendronate (oral) for at least another 12 months (until end of study)
Drug: Romosozumab
Romosozumab sub-cutaneous injections and placebo alendronate (oral) for 12 months followed by open-label alendronate (oral) for at least another 12 months (until end of study)
Other Name: sclerostin anitbody
Active Comparator: Alendronate
Oral alendronate plus placebo AMG 785 sub-cutaneous injections for 12 months, followed by open-label alendronate (oral) for at least another 12 months (until end of study)
Drug: Alendronate
Oral alendronate and placebo AMG 785 sub-cutaneous injections for 12 months, followed by open-label alendronate, (oral) for at least another 12 months (until end of study)
Other Name: biophosphantes, Fosamax

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Postmenopausal women with osteoporosis at high risk for fracture defined as:

  1. a hip BMD T-score of ≤-2.5 SD and a vertebral fracture or
  2. a hip BMD T-score of ≤-2.0 SD and a recent hip fracture or two vertebral fractures.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631214

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United States, Alabama
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Birmingham, Alabama, United States, 35294
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Peoria, Arizona, United States, 85381
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Tygerberg, South Africa, 7505
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Sevilla, Andalucía, Spain, 41009
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Sant Joan Despi, Cataluña, Spain, 08970
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A Coruña, Galicia, Spain, 15006
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Madrid, Spain, 28046
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Madrid, Spain, 28006
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Northwood, United Kingdom, HA6 2RN
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Reading, United Kingdom, RG2 0FT
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Sidcup, United Kingdom, DA14 6LT
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Staffordshire, United Kingdom, WS11 5XY
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Warwick, United Kingdom, CV34 5BW
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01631214     History of Changes
Other Study ID Numbers: 20110142, 2011-003142-41
Study First Received: May 24, 2012
Last Updated: April 9, 2015
Health Authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
Australia: Therapeutic Goods Administration
Austria: Bundesamt für Sicherheit im Gesundheitswesen (BASG) / AGES Medizinmarktaufsicht
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: Agência Nacional de Vigilância Sanitária
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Denmark: Sundhedsstyrelsen (Danish Health and Medicines Authority)
Dominican Republic: Ministerio de Salud Pública (MSP) Consejo Nacional de Bioética en Salud (CONABIOS)
Estonia: Ravimiamet (State Agency of Medicines)
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé ANSM
Germany: Paul-Ehrlich-Institut
Greece: EOF (National Organization for Medicines)
Guatemala: Ministerio de Salud Pública y Asistencia Social. Departamento de Regulación y Control de Productos Farmacéuticos y Afines
Hong Kong: Department of Health
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines, Directorate General of National Institute of Pharmacy (GYEMSZI-OGYI)
Ireland: Irish Medicines Board (IMB)
Israel: Ministry of Health
Italy: AIFA
Latvia: Zāļu valsts aģentūra (Latvia State Agency of Medicine)
Lithuania: Valstybinė vaistų kontrolės tarnyba (State Medicines Control Agency of Lithuania)
Mexico: Secretaría de Salud. Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
Netherlands: Centrale Commissie Mensgebonden Onderzoek
New Zealand: Medsafe
Norway: Statens Legemiddelverk (Norwegian Medicines Agency)
Peru: Instituto Nacional de Salud
Poland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: The National Agency for Medicines and Medical Devices, The National Ethics Committee for the Clinical Trials on Medicine
Russia: The Ministry of Healthcare of the Russian Federation (Minzdrav)
Slovakia: Štátny ústav pre kontrolu liečiv (Slovak institute for drug control)
Spain: AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS (AEMPS)
South Africa: Medicines Control Council
South Korea: The Ministry of Food and Drug Safety (MFDS)
Sweden: Läkemedelsverket (Medical Products Agency)
Taiwan: Taiwan Food & Drug Administration (TFDA)
Turkey: The Republic of Turkey Ministry of Health, Turkish Drug and Medical Device Institution
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Amgen:
Osteoporosis, Osteoporosis-postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Alendronate
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 29, 2015