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

Phase 3

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: Romosozumab 90 mg/mL; Drug: Placebo 90 mg/mL; Drug: Romosozumab 70 mg/mL; Drug: Placebo 70 mg/mL

• Registration Number: NCT02016716
• Lead Sponsor: Amgen

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.

Detailed 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.

Study Timeline

• Study Start: 2013-12-03
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-20
• Primary Completion: 2014-09-08
• Study Completion: 2014-12-08
• Disposition First Submitted: 2015-06-22
• Disposition First Submitted QC: 2015-06-22
• Disposition First Posted: 2015-07-15
• Status Verified: 2018-09
• Results First Submitted: 2018-09-24
• Results First Submitted QC: 2018-10-11
• Last Update Submitted: 2018-10-11
• Results First Posted: 2018-11-08
• Last Update Posted: 2018-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 294

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Romosozumab 90 mg/mL	Romosozumab 90 mg/mL	Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months.
Placebo 90 mg/mL	Placebo 90 mg/mL	Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months.
Romosozumab 70 mg/mL	Romosozumab 70 mg/mL	Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months.
Placebo 70 mg/mL	Placebo 70 mg/mL	Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine	Baseline and month 6	Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Femoral Neck BMD	Baseline and month 6	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.
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 Total Hip BMD	Baseline and month 6	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.
Percent Change From Baseline in Serum C-Telopeptide (CTX)	Baseline, month 1, month 3, and month 6

Trial Locations

Locations (1)

Research Site; 🇵🇱 Wroclaw, Poland