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

Phase 3

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: Denosumab (CP2); Drug: Denosumab (CP4)

• Registration Number: NCT02157948
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-06
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Disposition First Submitted: 2015-11-10
• Disposition First Submitted QC: 2015-11-10
• Disposition First Posted: 2015-12-09
• Status Verified: 2017-07
• Results First Submitted: 2017-07-18
• Results First Submitted QC: 2017-07-18
• Last Update Submitted: 2017-07-18
• Results First Posted: 2017-08-16
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 394

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab CP2	Denosumab (CP2)	Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
Denosumab CP4	Denosumab (CP4)	Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇵🇱 Warszawa, Poland