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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01631214
First received: May 24, 2012
Last updated: July 30, 2014
Last verified: July 2014

May 24, 2012
July 30, 2014
May 2012
January 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) ] [ Designated as safety issue: No ]
    Event driven
  • Incidence of new vertebral fracture [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01631214 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Recruiting
4000
March 2017
January 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

Female
55 Years to 90 Years
No
Contact: Amgen Call Center 866-572-6436
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   Dominican Republic,   Estonia,   Finland,   France,   Germany,   Greece,   Guatemala,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Latvia,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Norway,   Peru,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Turkey,   United Kingdom
 
NCT01631214
20110142, 2011-003142-41
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

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