A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

July 18, 2017 updated by: Amgen

A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

394

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 3M7
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • Research Site
    • Quebec
      • Westmout, Quebec, Canada, H3Z 1E5
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
      • Ballerup, Denmark, 2750
        • Research Site
      • Vejle, Denmark, 7100
        • Research Site
  • Poland
      • Bialystok, Poland, 15-351
        • Research Site
      • Gliwice, Poland, 44-100
        • Research Site
      • Kraków, Poland, 31-501
        • Research Site
      • Lodz, Poland, 90-558
        • Research Site
      • Lodz, Poland, 90-368
        • Research Site
      • Swidnik, Poland, 21-040
        • Research Site
      • Warszawa, Poland, 04-730
        • Research Site
  • United States
    • California
      • Santa Maria, California, United States, 93454
        • Research Site
      • South Lake Tahoe, California, United States, 96150
        • Research Site
    • Colorado
      • Lakewood, Colorado, United States, 80227
        • Research Site
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Research Site
    • Ohio
      • Akron, Ohio, United States, 44311
        • Research Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Subject has provided informed consent prior to any study-specific activities/procedures
  • Ambulatory postmenopausal women.
  • Age 55 years or older
  • Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck.

Exclusion Criteria:

  • Administration of osteoporosis treatments or bone active treatments within specific timeframes
  • Vitamin D deficiency
  • Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled)
  • Contraindications to denosumab therapy (e.g., hypocalcemia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Denosumab CP2
Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
Drug: Denosumab (CP2)
Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.
Other Names:
  • XGEVA®
Experimental: Denosumab CP4
Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
Drug: Denosumab (CP4)
Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Lumbar Spine BMD
Time Frame: Baseline and Month 12
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Baseline and Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX)
Time Frame: Baseline, month 1, month 6 and month 12
Baseline, month 1, month 6 and month 12
Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Time Frame: Baseline, month 1, month 6 and month 12
Baseline, month 1, month 6 and month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120187
  • 2013-001279-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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