Two-dose, Positive Drug Control, Multicentre, Randomized, Double-blind Study of Recombinant Human Parathyroid Hormone for Injection(rhPTH)(1-34) Once a Week to Treat Postmenopausal Osteoporosis Women for the Evaluation the Pharmacokinetics and Safety and to Explore Therapeutic Effects

Shenzhen Salubris Pharmaceuticals Co., Ltd.9 sites in 1 country148 target enrollmentOctober 1, 2018

ConditionsPostmenopausal Osteoporosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Postmenopausal Osteoporosis
Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
Enrollment: 148
Locations: 9
Primary Endpoint: The percentage change in bone density of the lumbar spine ( L1-4 ) from baseline to 24 weeks after treatment
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2018

End Date

August 31, 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female, capable of self - motivation , 45 years old ≤ age ≤ 75 years old.
•Natural menopause for 3 years or more; or surgical menopause for 3 years or more (surgery needs to be performed after 40 years old), for women with surgical menopause, estradiol(E2)\< 25 pg/ml and follicle stimulating hormone(FSH) \> 40mIU/ml should be met.
•Weight ≥ 40kg , 18 ≤ body mass index(BMI)≤ 30 .
•Meets one of the following diagnostic criteria for osteoporosis, and ≥ 3 vertebral bodies of L1-4 can be measured by bone mineral density using the DXA method.
•Brittle fracture of the hip or vertebral body, and the bone density measurement T- score\< -1.
•The T- score of the central axis bone mineral density or the 1/3 bone density of the distal radius of the tibia was ≤-2.5 measured by DXA .
•Bone density measurements were consistent with low bone mass ( -2.5 \< T- value \< -1.0 ) and combined with proximal humerus, pelvic or forearm distal brittle fractures.
•to participate in the trial and sign the informed consent form.

Exclusion Criteria

•to have diseases affecting calcium or bone metabolism that are not effectively controlled, such as primary hyperparathyroidism or hyperthyroidism, Paget's bone disease, hypercalcemia, hypocalcemia, active urolithiasis.
•Secondary osteoporosis, such as osteomalacia, rheumatoid arthritis, gout, multiple myeloma, etc.
•Severe lumbar anatomical abnormalities which affecting DXA bone mineral density measurement, such as severe scoliosis.
•Patients who have been treated for anti-osteoporosis before random enrollment:
•Patients who received parathyroid hormone(PTH) therapy before random enrollment (including clinical trials of similar products).
•Patients who received bisphosphonate injection within 1 year prior to random enrollment or received bisphosphonate oral administration within 3 months for \> 2 weeks prior to enrollment.
•Systemic treatment of androgen, estrogen, and selective estrogen receptor modulator(SERM) preparations within 3 months \> 2 weeks prior to random enrollment.
•Three months before randomized to receive of heparin, warfarin, anticonvulsants (except benzodiazepines), digoxin accumulated for\> 2 weeks.
•In the 3 months prior to random enrollment , received calcitonin, vitamin K preparation, active vitamin D3 preparation, oral or intravenous glucocorticoid treatment for \> 4 weeks.
•Suffering from severe kidney disease, uncontrolled high blood pressure ( ≥150/100 mmHg ), symptomatic ischemic heart disease, cerebral infarction or obliterative atherosclerosis, malignancy, and other serious underlying diseases.

Outcomes

Primary Outcomes

The percentage change in bone density of the lumbar spine ( L1-4 ) from baseline to 24 weeks after treatment

Time Frame: Baseline，week 24

bone mineral density(BMD) measured by dual energy x-ray absorptiometry (DXA)

Secondary Outcomes

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(Baseline，week 24)
The percentage change of total hip bone density from baseline to 24 weeks after G56W1 treatment(Baseline，week 24)
Maximum plasma concentration (Cmax)(Baseline，week 1，week 4，week 12，week 24)
Area under the plasma concentration versus time curve (AUC)(Baseline，week 1，week 4，week 12，week 24)
Elimination half-life（t1/2）(Baseline，week 1，week 4，week 12，week 24)
Time to maximum plasma concentration（Tmax）(Baseline，week 1，week 4，week 12，week 24)