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A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02016716
First received: December 10, 2013
Last updated: May 31, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.

Condition Intervention Phase
Postmenopausal Osteoporosis Drug: Romosozumab 90 mg/mL Drug: Placebo 90 mg/mL Drug: Romosozumab 70 mg/mL Drug: Placebo 70 mg/mL Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate the Noninferiority of Romosozumab at a 90 mg/mL Concentration Compared With a 70 mg/mL Concentration in Postmenopausal Women With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • The primary endpoint is the percent change from baseline in DXA BMD at the lumbar spine (noninferiority) [ Time Frame: 6 months ]
    The primary endpoint is the percent change from baseline in DXA BMD at the lumbar spine (noninferiority)


Secondary Outcome Measures:
  • percent change from baseline in DXA BMD at the total hip [ Time Frame: Month 6 ]
    percent change from baseline in DXA BMD at the total hip • percent change from baseline in DXA BMD at the femoral neck • percent change from baseline in BTMs P1NP and CTX


Enrollment: 294
Actual Study Start Date: December 3, 2013
Study Completion Date: December 8, 2014
Primary Completion Date: September 8, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Romosozumab 90 mg/mL
Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months.
Drug: Romosozumab 90 mg/mL
Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).
Other Names:
  • AMG 785
  • EVENITY™
Experimental: Placebo 90 mg/mL
Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months.
Drug: Placebo 90 mg/mL
Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.
Experimental: Romosozumab 70 mg/mL
Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months.
Drug: Romosozumab 70 mg/mL
Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.
Other Names:
  • AMG 785
  • EVENITY™
Placebo Comparator: Placebo 70 mg/mL
Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months.
Drug: Placebo 70 mg/mL
Placebo administered as 3 SC injections with the 1.0 mL glass PFS.

Detailed Description:

Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the following treatment groups:

  • Romosozumab 90 mg/mL
  • Placebo 90 mg/mL
  • Romosozumab 70 mg/mL
  • Placebo 70 mg/mL

After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9.

For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.

  Eligibility

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

  • BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND
  • a history of fragility fracture or at least 2 other risk factors

Exclusion Criteria:

  • BMD T score < -3.50 at the total hip or femoral neck.
  • History of hip fracture.
  • 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.
  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: NCT02016716

Locations
United States, Georgia
Research Site
Gainesville, Georgia, United States, 30501
United States, Maryland
Research Site
Bethesda, Maryland, United States, 20817
Czechia
Research Site
Brno, Czechia, 602 00
Research Site
Klatovy, Czechia, 339 01
Research Site
Uherske Hradiste, Czechia, 686 01
Poland
Research Site
Gdynia, Poland, 81-384
Research Site
Gliwice, Poland, 44-100
Research Site
Katowice, Poland, 40-040
Research Site
Kraków, Poland, 31-501
Research Site
Swidnik, Poland, 21-040
Research Site
Warszawa, Poland, 01-192
Research Site
Wroclaw, Poland, 50-088
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02016716     History of Changes
Other Study ID Numbers: 20120156
2013-000434-35 ( EudraCT Number )
Study First Received: December 10, 2013
Last Updated: May 31, 2017

Keywords provided by Amgen:
Postmenopausal Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 20, 2017