A Randomized Phase 3 Study to Evaluate 2 Different Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02016716
First received: December 10, 2013
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

Purpose of this study is to evaluate the 2 formulations of Romosozumab in Postmenopausal Women With Osteoporosis.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: Romosozumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate 2 Different Formulations of Romosozumab 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: romo A
romosozumab formulation A
Drug: Romosozumab
Active formulation (A) compared with Active formulation (B )
Other Name: AMG785
Placebo Comparator: placebo A
placebo formulation A
Drug: Placebo
placebo formulation A compared with placebo formulation B
Other Name: AMG785
Active Comparator: romo B
romosozumab formulation B
Drug: Romosozumab
Active formulation (A) compared with Active formulation (B )
Other Name: AMG785
Placebo Comparator: placebo B
placebo formulation B
Drug: Placebo
placebo formulation A compared with placebo formulation B
Other Name: AMG785

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders 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
United Osteoporosis Center
Gainesville, Georgia, United States, 30501
Research Site
Gainesville, Georgia, United States, 30501
United States, Maryland
Bethesda Health Research
Bethesda, Maryland, United States, 20817
Research Site
Bethesda, Maryland, United States, 20817
Czech Republic
Research Site
Brno, Czech Republic, 602 00
Osteologicke centrum
Brno, Czech Republic, 602 00
Klatovska nemocnice as
Klatovy, Czech Republic, 339 01
Research Site
Klatovy, Czech Republic, 339 01
Research Site
Uherske Hradiste, Czech Republic, 686 01
Medical Plus
Uherske Hradiste, Czech Republic, 686 01
Poland
Research Site
Gdynia, Poland, 81-384
Synexus Polska
Gdynia, Poland, 81-384
Gabinet Diagnostyki
Gliwice, Poland, 44-100
Research Site
Gliwice, Poland, 44-100
Synexus Polska
Katowice, Poland, 40-040
Research Site
Katowice, Poland, 40-040
Krakowskie Centrum Medyczne
Kraków, Poland, 31-501
Research Site
Kraków, Poland, 31-501
Research Site
Swidnik, Poland, 21-040
Lubelskie Centrum Diagnostyczne
Swidnik, Poland, 21-040
Research Site
Warszawa, Poland, 01-192
Synexus Polska
Warszawa, Poland, 01-192
Synexus Polska
Wroclaw, Poland, 50-088
Research Site
Wroclaw, Poland, 50-088
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02016716     History of Changes
Other Study ID Numbers: 20120156
Study First Received: December 10, 2013
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Postmenopausal Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 21, 2014