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

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Denosumab (CP2)
Denosumab (CP4)
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, osteoporosis, postmenopausal, denosumab, women

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Denosumab CP2

Denosumab CP4

Arm Description

Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.

Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Lumbar Spine BMD
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Secondary Outcome Measures

Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX)
Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)

Full Information

First Posted
June 4, 2014
Last Updated
July 18, 2017
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02157948
Brief Title
A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
Official Title
A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
394 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Denosumab CP2
Arm Type
Active Comparator
Arm Description
Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
Arm Title
Denosumab CP4
Arm Type
Experimental
Arm Description
Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
Intervention Type
Drug
Intervention Name(s)
Denosumab (CP2)
Other Intervention Name(s)
XGEVA®
Intervention Description
Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.
Intervention Type
Drug
Intervention Name(s)
Denosumab (CP4)
Intervention Description
Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Lumbar Spine BMD
Description
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time Frame
Baseline and Month 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX)
Time Frame
Baseline, month 1, month 6 and month 12
Title
Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Time Frame
Baseline, month 1, month 6 and month 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
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
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Research Site
City
South Lake Tahoe
State/Province
California
ZIP/Postal Code
96150
Country
United States
Facility Name
Research Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80227
Country
United States
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
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Research Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Research Site
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
Research Site
City
Westmout
State/Province
Quebec
ZIP/Postal Code
H3Z 1E5
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Research Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Research Site
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
Research Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Research Site
City
Gliwice
ZIP/Postal Code
44-100
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-368
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-558
Country
Poland
Facility Name
Research Site
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland

12. IPD Sharing Statement

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

Learn more about this trial

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

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