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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: June 7, 2017
Last verified: June 2017
May 24, 2012
June 7, 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: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Postmenopausal Women With Osteoporosis
  • 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
  • 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
  • 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)
    Intervention: Drug: Romosozumab
  • 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)
    Intervention: Drug: Alendronate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4093
November 1, 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 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

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
June 2017

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