G56W1 in Women With Postmenopausal Osteoporosis

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 31, 2020

Interventions

  • Biological: rhPTH(1-34) 28.2μg
    • Administered by subcutaneous injection
  • Biological: rhPTH(1-34) 56.5μg
    • Administered by subcutaneous injection
  • Biological: teriparatide acetate(Teribone™)
    • Administered by subcutaneous injection

Arms, Groups and Cohorts

  • Experimental: rhPTH(1-34) 28.2μg
    • Participants received 28.2μg rhPTH(1-34)administered by subcutaneous injection once a week for 24 weeks.
  • Experimental: rhPTH(1-34) 56.5μg
    • Participants received 56.5μg rhPTH(1-34)administered by subcutaneous injection once a week for 24 weeks.
  • Active Comparator: teriparatide acetate(Teribone™)
    • Participants received 56.5μg teriparatide acetate(Teribone™) administered by subcutaneous injection once a week for 24 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
    • Time Frame: Baseline,week 24
    • Central lab will be used
  • The percentage change of total hip bone density from baseline to 24 weeks after G56W1 treatment
    • Time Frame: Baseline,week 24
    • BMD measured by DXA
  • Maximum plasma concentration (Cmax)
    • Time Frame: Baseline,week 1,week 4,week 12,week 24
    • serum parathyroid hormone(PTH) will be tested for all pharmacokinetics parameters
  • Area under the plasma concentration versus time curve (AUC)
    • Time Frame: Baseline,week 1,week 4,week 12,week 24
    • serum PTH will be tested for all pharmacokinetics parameters
  • Time to maximum plasma concentration(Tmax)
    • Time Frame: Baseline,week 1,week 4,week 12,week 24
    • serum PTH will be tested for all pharmacokinetics parameters
  • Elimination half-life(t1/2)
    • Time Frame: Baseline,week 1,week 4,week 12,week 24
    • serum PTH will be tested for all pharmacokinetics parameters

Participating in This Clinical Trial

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.

1. Brittle fracture of the hip or vertebral body, and the bone density measurement T- score< -1.0.

2. 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 .

3. 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:

1. Patients who received parathyroid hormone(PTH) therapy before random enrollment (including clinical trials of similar products).

2. 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.

3. Systemic treatment of androgen, estrogen, and selective estrogen receptor modulator(SERM) preparations within 3 months > 2 weeks prior to random enrollment.

4. Three months before randomized to receive of heparin, warfarin, anticonvulsants (except benzodiazepines), digoxin accumulated for> 2 weeks.

5. 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.
  • Laboratory tests indicates abnormal, including any of the following indicators abnormalities (according to the normal range of each center, after consideration of the investigator with clinical considerations, such as caused by operational procedures, etc., after discussion with the sponsor, may allow retesting once) .

1. Alkaline phosphatase(ALP)>1.5 times the upper limit of normal.

2. Aspartate transaminase(AST) or alanine aminotransferase(ALT) or total bilirubin(TBIL) > 2.0 times the upper limit of normal.

3. Glycated hemoglobin(HbA1c )≥ 7.0% .

4. White blood cell(WBC)< 3.5×10^9 /L , Hb<100g/L or Plt<90×10^9 /L.

5. Thyroid-stimulating hormone(TSH)<0.01 mIU/L (mU/L) or TSH>10 mIU/L (mU/L) .

6. Parathyroid hormone(PTH)>1.5 times the upper limit of normal.

7. Serum creatinine(SCr)>1.2 times the upper limit of normal.

8. Serum total calcium(SCa)> normal upper limit.

  • Subjects who had significant clinical significance including HIV , hepatitis B, hepatitis C, and syphilis ( hepatitis B virus carriers can be enrolled ) .
  • Heavy Smoking (average of more than 10 / day) and / or alcohol addicted (converted to pure alcohol 30 ml / day or more) .
  • Recent drug abuse or drug dependence evidence.
  • Those who are allergic to test drugs / control drugs or biological products.
  • Included in other interventional clinical trials within 3 months of the study.
  • Been undergone radiation therapy for bones.
  • Mental illness or any cause of cognitive impairment.
  • Patients who were considered unsuitable for the study based on risk benefits by investigators.

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shenzhen Salubris Pharmaceuticals Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Weibo Xia, Prof., Principal Investigator, Peking Union Medical College

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