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

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ClinicalTrials.gov Identifier: NCT02016716
Recruitment Status : Completed
First Posted : December 20, 2013
Results First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 294 participants
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
Actual Study Start Date : December 3, 2013
Actual Primary Completion Date : September 8, 2014
Actual Study Completion Date : December 8, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Romosozumab

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine [ Time Frame: Baseline and month 6 ]
    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).


Secondary Outcome Measures :
  1. Percent Change From Baseline in Total Hip BMD [ Time Frame: Baseline and month 6 ]
    Total hip BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline total hip BMD T-score.

  2. Percent Change From Baseline in Femoral Neck BMD [ Time Frame: Baseline and month 6 ]
    Femoral neck BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline femoral neck BMD T-score.

  3. Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP) [ Time Frame: Baseline, month 1, month 3, and month 6 ]
  4. Percent Change From Baseline in Serum C-Telopeptide (CTX) [ Time Frame: Baseline, month 1, month 3, and month 6 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
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
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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): NCT02016716


Locations
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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
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02016716    
Other Study ID Numbers: 20120156
2013-000434-35 ( EudraCT Number )
First Posted: December 20, 2013    Key Record Dates
Results First Posted: November 8, 2018
Last Update Posted: November 8, 2018
Last Verified: September 2018
Keywords provided by Amgen:
Postmenopausal Osteoporosis
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs