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

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Romosozumab 90 mg/mL
Placebo 90 mg/mL
Romosozumab 70 mg/mL
Placebo 70 mg/mL
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Postmenopausal Osteoporosis

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Romosozumab 90 mg/mL

Placebo 90 mg/mL

Romosozumab 70 mg/mL

Placebo 70 mg/mL

Arm Description

Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months.

Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months.

Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months.

Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

Secondary Outcome Measures

Percent Change From Baseline in Total Hip BMD
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.
Percent Change From Baseline in Femoral Neck BMD
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.
Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP)
Percent Change From Baseline in Serum C-Telopeptide (CTX)

Full Information

First Posted
December 10, 2013
Last Updated
October 11, 2018
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02016716
Brief Title
A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 3, 2013 (Actual)
Primary Completion Date
September 8, 2014 (Actual)
Study Completion Date
December 8, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
Postmenopausal Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
294 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Romosozumab 90 mg/mL
Arm Type
Experimental
Arm Description
Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months.
Arm Title
Placebo 90 mg/mL
Arm Type
Experimental
Arm Description
Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months.
Arm Title
Romosozumab 70 mg/mL
Arm Type
Experimental
Arm Description
Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months.
Arm Title
Placebo 70 mg/mL
Arm Type
Placebo Comparator
Arm Description
Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months.
Intervention Type
Drug
Intervention Name(s)
Romosozumab 90 mg/mL
Other Intervention Name(s)
AMG 785, EVENITY™
Intervention Description
Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).
Intervention Type
Drug
Intervention Name(s)
Placebo 90 mg/mL
Intervention Description
Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.
Intervention Type
Drug
Intervention Name(s)
Romosozumab 70 mg/mL
Other Intervention Name(s)
AMG 785, EVENITY™
Intervention Description
Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.
Intervention Type
Drug
Intervention Name(s)
Placebo 70 mg/mL
Intervention Description
Placebo administered as 3 SC injections with the 1.0 mL glass PFS.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine
Description
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Time Frame
Baseline and month 6
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Total Hip BMD
Description
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.
Time Frame
Baseline and month 6
Title
Percent Change From Baseline in Femoral Neck BMD
Description
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.
Time Frame
Baseline and month 6
Title
Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP)
Time Frame
Baseline, month 1, month 3, and month 6
Title
Percent Change From Baseline in Serum C-Telopeptide (CTX)
Time Frame
Baseline, month 1, month 3, and month 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Research Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Research Site
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Research Site
City
Klatovy
ZIP/Postal Code
339 01
Country
Czechia
Facility Name
Research Site
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
Facility Name
Research Site
City
Gliwice
ZIP/Postal Code
44-100
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Research Site
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

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

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