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

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ClinicalTrials.gov Identifier: NCT01631214
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Condition or disease Intervention/treatment Phase
Postmenopausal Women With Osteoporosis Drug: Romosozumab Drug: Alendronate Drug: Placebo Romosozumab Drug: Placebo Alendronate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4093 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : May 4, 2012
Primary Completion Date : February 27, 2017
Study Completion Date : June 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arm Intervention/treatment
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 will be presented in a single-use 1 mL prefilled syringe (PFS) as a sterile, clear, colorless, and preservative-free liquid containing 70 mg of romosozumab per mL in 55 mM acetate and 13 mM calcium, containing 6.0% w/v sucrose and 0.006% w/v polysorbate 20 at pH 5.2.
Other Name: sclerostin anitbody
Drug: Placebo Alendronate
Placebo to ALN will be presented in identical containers and stored/packaged the same as ALN.
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
Blinded ALN will be manufactured by Merck & Co Inc., packaged by Patheon Inc., and labeled and distributed using Amgen clinical study drug distribution procedures. Blinded ALN will be presented as a blister pack containing 10 tablets.
Other Name: biophosphantes, Fosamax
Drug: Placebo Romosozumab
Placebo to romosozumab will be presented in identical containers and stored/packaged the same as romosozumab
Other Name: Placebo AMG 785



Primary Outcome Measures :
  1. Incidence of clinical fracture [ Time Frame: From baseline until the date of first clinical fracture assessed (approximately 24 months) ]
    Event driven

  2. Incidence of new vertebral fracture [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Incidence of fracture [ Time Frame: 12 months ]
  2. Percent changes in DXA Bone Mineral Density from baseline to 12 months [ Time Frame: 12 months ]
  3. Incidence of fracture [ Time Frame: From baseline until the date of first clinical fracture assessed (approximately 24 months) ]
    Event driven

  4. Percent changes in DXA Bone Mineral Density from baseline to 24 months [ Time Frame: 24 Months ]
  5. Percent changes in DXA Bone Mineral Density from baseline to 36 months [ Time Frame: 36 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes 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 one moderate/severe or two mild vertebral fractures or
  2. a hip BMD T-score of ≤-2.0 SD and either a recent hip fracture or two moderate/severe 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631214


  Show 317 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01631214     History of Changes
Other Study ID Numbers: 20110142
2011-003142-41 ( EudraCT Number )
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Antibodies, Monoclonal
Bone Density Conservation Agents
Physiological Effects of Drugs
Immunologic Factors