A Phase III, Randomized, Double-Blind, Parallel Group, Multicenter Study to Compare Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of BP16 Versus EU-Prolia® in Women with Post- Menopausal Osteoporosis

Conditions

Post-Menopausal Osteoporosis

Brief summary

Percent change from baseline (%CfB) in lumbar spine bone mineral density (LS-BMD) at Week 52, AUEC of sCTX from Week 0 up to Week 26 (AUEC0-26w).

Detailed description

Percent change in bone turnover markers (sCTX and P1NP) at Week 26, Week 52, and Week 78., %CfB in LS-BMD at Week 26 and Week 78., %CfB in total hip and femoral neck BMD at Week 26, Week 52, and Week 78., Incidence of fracture up to Week 52 and Week 78., Ctrough: Serum trough concentration of denosumab at Week 26, Week 52, and Week 78., Incidence, nature, and severity of adverse events (AE) including adverse drug reactions (ADRs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 as defined by TEAEs,SAEs, related TEAEs, and related SAEs., Physical examination, vital signs, and 12-lead ECG., Laboratory parameters (hematology, clinical chemistry, and urinalysis)., Incidence and titer of antidrug antibody to denosumab at Week 0, Week 12, Week 26, Week 52, and Week 78., Incidence of neutralizing antibody in all the ADA-positive subjects.

Related papers

No related papers found yet.

Interventions

DRUGBP16

DRUGDENOSUMAB

DRUGCALCIUM CARBONATE

DRUGVitamin D3 400 IU Capsules

DRUGsoft

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline (%CfB) in lumbar spine bone mineral density (LS-BMD) at Week 52, AUEC of sCTX from Week 0 up to Week 26 (AUEC0-26w).	—

Secondary

Measure	Time frame
Percent change in bone turnover markers (sCTX and P1NP) at Week 26, Week 52, and Week 78., %CfB in LS-BMD at Week 26 and Week 78., %CfB in total hip and femoral neck BMD at Week 26, Week 52, and Week 78., Incidence of fracture up to Week 52 and Week 78., Ctrough: Serum trough concentration of denosumab at Week 26, Week 52, and Week 78., Incidence, nature, and severity of adverse events (AE) including adverse drug reactions (ADRs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 as defined by TEAEs,SAEs, related TEAEs, and related SAEs., Physical examination, vital signs, and 12-lead ECG., Laboratory parameters (hematology, clinical chemistry, and urinalysis)., Incidence and titer of antidrug antibody to denosumab at Week 0, Week 12, Week 26, Week 52, and Week 78., Incidence of neutralizing antibody in all the ADA-positive subjects.	—

Measure

Time frame

Percent change in bone turnover markers (sCTX and P1NP) at Week 26, Week 52, and Week 78., %CfB in LS-BMD at Week 26 and Week 78., %CfB in total hip and femoral neck BMD at Week 26, Week 52, and Week 78., Incidence of fracture up to Week 52 and Week 78., Ctrough: Serum trough concentration of denosumab at Week 26, Week 52, and Week 78., Incidence, nature, and severity of adverse events (AE) including adverse drug reactions (ADRs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 as defined by TEAEs,SAEs, related TEAEs, and related SAEs., Physical examination, vital signs, and 12-lead ECG., Laboratory parameters (hematology, clinical chemistry, and urinalysis)., Incidence and titer of antidrug antibody to denosumab at Week 0, Week 12, Week 26, Week 52, and Week 78., Incidence of neutralizing antibody in all the ADA-positive subjects.

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Countries

Bulgaria, Estonia, Hungary, Latvia, Poland, Slovakia

Outcome results

None listed