A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

Study Overview
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Brief Summary
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This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

Official Title
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A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Denosumab (CP2)
* Drug: Denosumab (CP4)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided informed consent prior to any study-specific activities/procedures Ambulatory postmenopausal women. Age 55 years or older Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck. Exclusion Criteria: Administration of osteoporosis treatments or bone active treatments within specific timeframes Vitamin D deficiency Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled) Contraindications to denosumab therapy (e.g., hypocalcemia)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 100 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Denosumab CP2<br>Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year. | Drug: Denosumab (CP2)<br>* Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.<br>* Other names: XGEVA®;|
| Experimental: Denosumab CP4<br>Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year. | Drug: Denosumab (CP4)<br>* Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Lumbar Spine BMD | Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX) |  | Baseline, month 1, month 6 and month 12 | 
| Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) |  | Baseline, month 1, month 6 and month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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denosumab, women, postmenopausal osteoporosis, osteoporosis, postmenopausal