This study will assess the pharmacokinetics and safety and explore therapeutic effects with once-weekly recombinant human parathyroid hormone for injection ( 1-34 ) ( G56W1 ) in women with post-menopausal osteoporosis .The anticipated time on study treatment is 24 weeks, and the target sample size is 148 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
148
Administered by subcutaneous injection
Administered by subcutaneous injection
Administered by subcutaneous injection
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Chongqing Three Gorges Central Hospital
Wanzhou, Chongqing Municipality, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The percentage change in bone density of the lumbar spine ( L1-4 ) from baseline to 24 weeks after treatment
bone mineral density(BMD) measured by dual energy x-ray absorptiometry (DXA)
Time frame: Baseline,week 24
Evaluate the rate of change of Procollagen I N-terminal peptide(PINP),Serum cross-linked C-terminal telopeptide of type I collagen(s-CTX) ,Bone alkaline phosphatase(BALP) , and blood calcium from baseline
Central lab will be used
Time frame: Baseline,week 24
The percentage change of total hip bone density from baseline to 24 weeks after G56W1 treatment
BMD measured by DXA
Time frame: Baseline,week 24
Maximum plasma concentration (Cmax)
serum parathyroid hormone(PTH) will be tested for all pharmacokinetics parameters
Time frame: Baseline,week 1,week 4,week 12,week 24
Area under the plasma concentration versus time curve (AUC)
serum PTH will be tested for all pharmacokinetics parameters
Time frame: Baseline,week 1,week 4,week 12,week 24
Time to maximum plasma concentration(Tmax)
serum PTH will be tested for all pharmacokinetics parameters
Time frame: Baseline,week 1,week 4,week 12,week 24
Elimination half-life(t1/2)
serum PTH will be tested for all pharmacokinetics parameters
Time frame: Baseline,week 1,week 4,week 12,week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
The West China Second UniversityHospital of Sichuan University
Chengdu, Sichuan, China
West China Hospital,Sichuan University
Chengdu, Sichuan, China
Tianjin Hospital
Tianjin, Tianjin Municipality, China