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

NCT02016716 | Completed Phase 3 Results

• 2 other identifiers: 201201562013-000434-35
• Study Type: interventional
• Target: 294
• Locations: 3 countries
• Sites: 12

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.

Conditions

Postmenopausal Osteoporosis

Keywords

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and month 6

Secondary Outcomes (4)

• Percent Change From Baseline in Total Hip BMD

  Baseline and month 6

• Percent Change From Baseline in Femoral Neck BMD

  Baseline and month 6

• Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP)

  Baseline, month 1, month 3, and month 6

• Percent Change From Baseline in Serum C-Telopeptide (CTX)

  Baseline, month 1, month 3, and month 6

Study Arms (4)

Romosozumab 90 mg/mL

EXPERIMENTAL

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

Placebo 90 mg/mL

EXPERIMENTAL

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

Drug: Placebo 90 mg/mL

Romosozumab 70 mg/mL

EXPERIMENTAL

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

Placebo 70 mg/mL

PLACEBO COMPARATOR

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

Drug: Placebo 70 mg/mL

Interventions

Romosozumab 90 mg/mL DRUG

Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).

Also known as: AMG 785, EVENITY™

Romosozumab 90 mg/mL

Placebo 90 mg/mL DRUG

Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.

Placebo 90 mg/mL

Romosozumab 70 mg/mL DRUG

Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.

Also known as: AMG 785, EVENITY™

Romosozumab 70 mg/mL

Placebo 70 mg/mL DRUG

Placebo administered as 3 SC injections with the 1.0 mL glass PFS.

Placebo 70 mg/mL

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (12)

Research Site

Gainesville, Georgia, 30501, United States

Location

Research Site

Bethesda, Maryland, 20817, United States

Location

Research Site

Brno, 602 00, Czechia

Location

Research Site

Klatovy, 339 01, Czechia

Location

Research Site

Uherské Hradiště, 686 01, Czechia

Location

Research Site

Gdynia, 81-384, Poland

Location

Research Site

Gliwice, 44-100, Poland

Location

Research Site

Katowice, 40-040, Poland

Location

Research Site

Krakow, 31-501, Poland

Location

Research Site

Świdnik, 21-040, Poland

Location

Research Site

Warsaw, 01-192, Poland

Location

Research Site

Wroclaw, 50-088, Poland

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

romosozumab

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 20, 2013
• Study Start: December 3, 2013
• Primary Completion: September 8, 2014
• Study Completion: December 8, 2014
• Last Updated: November 8, 2018
• Results First Posted: November 8, 2018

Record last verified: 2018-09

Locations

US (2); CZ (3); PL (7)