evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)
this is a randomized, double-blinded, parallel, active-controlled clinical phase III study. the primary objective is to evaluate the efficacy and safety of CMAB807 treatment compared with Prolia in Chinese postmenopausal women with osteoporosis at high risk of fracture. Subjects should sequentially enrolled according to the protocol in one of two arms. Subjects who entered in test arm would receive 60mg of CMAB807 subcutaneously every 6 months for one year, while those who entered in control arm should receive 60mg of Prolia subcutaneously every 6 months for one year. Meanwhile, every subject should taking 600mg calcium and 400IU vitamin D daily from successfully screening to the end of study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
278
mAb targeting RANKL, human monoclonal antibody targeting RANKL
mAb targeting RANKL, human monoclonal antibody targeting RANKL
Peking Union Medical College Hosptial
Beijing, Beijing Municipality, China
BMD percentage change from baseline at lumbar spine(L1~L4)
Percentage change from baseline at lumbar spine(L1\~L4) by dual-energy X-ray absorptiometry to month 12 of treatment and compare between two arms. Percentage change of lumbar spine BMD from baseline to at month 12 of treatment=(BMD at month 12 of treatment - BMD at baseline)/BMD at baseline\*100%
Time frame: baseline, at 12 months
BMD percentage change from baseline at lumbar spine(L1~L4)
Percentage change from baseline at lumbar spine(L1\~L4) by dual-energy X-ray absorptiometry to month 6 of treatment and compare between two arms. Percentage change of lumbar spine BMD from baseline to at month 12 of treatment=(BMD at month 12 of treatment - BMD at baseline)/BMD at baseline\*100%
Time frame: baseline, at 6 months
BMD percentage change from baseline at total hip, trochanter and femoral neck
Pencentage change from baseline at total hip, trochanter and fremoral neck by dual-energy-X-ray absorptiometry to month 6 and month 12 of treatment, and compare between two arms. Percentage to total hip, trochanter and femoral neck BMD from baseline at month 6 or month 12 of treatment=(BMD at month 6 or month 12 of treatment - BMD at baseline)/BMD at baseline\*100%
Time frame: baseline, at month 6, at month 12
Serum CTX1 and P1NP concentration percentage change from baseline
Fasting serum CTX1 and P1NP samples should be collected. Percentage changes of serum CTX1 or P1NP concentrations from baseline at month 1, month 3, month 6, month 9 and at month 12 of treatment=(serum concentrations at month 1, month 3, month 6, month 9 and month 12 - serum concentration at baseline)/serum concentration at baseline\*100%
Time frame: baseline, at month 1, at month 3, at month 6, at month 9,and at month 12
Proporation of new osteoporotic fractures(vertebrae, total hip and non-vertebrae) occurring within the study period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Osteoporotic fracture is defined as the fracture occurred when subject suffers minor trauma or during daily activities. Common occurrence sites are vertebral body, hip, distal forearm, proximal humerus and pelvis, etc
Time frame: baseline, at month 12
Adeverse events and serious adverse events
Evaluation of the drug reactions, changes in physical examination findings, changes in vital signs, stomatological examination, clinical laboratory testing for systemic safety(including complete blood count, urinalysis, clinical chemistries, coagulation function, liver function, renal function, parathyroid function), and electrocardiography
Time frame: baseline ,at 12 months
Immunogenicity
Binding antibody and neutralizing antibody formation assays were used to assess number of subjects with anti-denosumab antibody
Time frame: baseline, at 12 months
Population pharmacokinetics analysis
The pharmacokinetic parameters were described statistically, such as population typical value of clearance rate, estimation precision of typical value, confindence interval of typical value, and inter individual variation
Time frame: baseline, at 12 months