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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Romosozumab 90 mg/mL
* Drug: Placebo 90 mg/mL
* Drug: Romosozumab 70 mg/mL
* Drug: Placebo 70 mg/mL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Romosozumab 90 mg/mL<br>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<br>* Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).<br>* Other names: EVENITY™;|
| Experimental: Placebo 90 mg/mL<br>Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months. | Drug: Placebo 90 mg/mL<br>* Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.<br>|
| Experimental: Romosozumab 70 mg/mL<br>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<br>* Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.<br>* Other names: EVENITY™;|
| Placebo Comparator: Placebo 70 mg/mL<br>Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months. | Drug: Placebo 70 mg/mL<br>* Placebo administered as 3 SC injections with the 1.0 mL glass PFS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal Osteoporosis