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

Postmenopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016716
• Other study ID #: 20120156
• Secondary ID: 2013-000434-35
• Status: Completed
• Phase: Phase 3
• Start date: December 3, 2013
• Est. completion date: December 8, 2014

Study information

• Verified date: September 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: December 8, 2014
• Est. primary completion date: September 8, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• Romosozumab 90 mg/mL
Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).
• Placebo 90 mg/mL
Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.
• Romosozumab 70 mg/mL
Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.
• Placebo 70 mg/mL
Placebo administered as 3 SC injections with the 1.0 mL glass PFS.

Locations

Country	Name	City	State
Czechia	Research Site	Brno
Czechia	Research Site	Klatovy
Czechia	Research Site	Uherske Hradiste
Poland	Research Site	Gdynia
Poland	Research Site	Gliwice
Poland	Research Site	Katowice
Poland	Research Site	Kraków
Poland	Research Site	Swidnik
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
United States	Research Site	Bethesda	Maryland
United States	Research Site	Gainesville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Czechia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and month 6
Secondary	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.	Baseline and month 6
Secondary	Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP)		Baseline, month 1, month 3, and month 6
Secondary	Percent Change From Baseline in Serum C-Telopeptide (CTX)		Baseline, month 1, month 3, and month 6

External Links

•   AmgenTrials clinical trials website