We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

May 24, 2012
June 29, 2012
December 26, 2017
May 4, 2012
February 27, 2017   (Final data collection date for primary outcome measure)
  • Incidence of clinical fracture [ Time Frame: From baseline until the date of first clinical fracture assessed (approximately 24 months) ]
    Event driven
  • Incidence of new vertebral fracture [ Time Frame: 24 months ]
Same as current
Complete list of historical versions of study NCT01631214 on ClinicalTrials.gov Archive Site
  • Incidence of fracture [ Time Frame: 12 months ]
  • Percent changes in DXA Bone Mineral Density from baseline to 12 months [ Time Frame: 12 months ]
  • Incidence of fracture [ Time Frame: From baseline until the date of first clinical fracture assessed (approximately 24 months) ]
    Event driven
  • Percent changes in DXA Bone Mineral Density from baseline to 24 months [ Time Frame: 24 Months ]
  • Percent changes in DXA Bone Mineral Density from baseline to 36 months [ Time Frame: 36 Months ]
Same as current
Not Provided
Not Provided
 
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
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
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postmenopausal Women With Osteoporosis
  • 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: 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
  • Drug: Placebo Alendronate
    Placebo to ALN will be presented in identical containers and stored/packaged the same as ALN.
  • 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)
    Interventions:
    • Drug: Romosozumab
    • Drug: Placebo Alendronate
  • 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)
    Interventions:
    • Drug: Alendronate
    • Drug: Placebo Romosozumab
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4093
June 29, 2017
February 27, 2017   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: Female
55 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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,   United States
Czech Republic
 
NCT01631214
20110142
2011-003142-41 ( EudraCT Number )
Yes
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP