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G56W1 in Women With Postmenopausal Osteoporosis

Primary Purpose

Postmenopausal Osteoporosis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
rhPTH(1-34) 28.2μg
rhPTH(1-34) 56.5μg
teriparatide acetate(Teribone™)
Sponsored by
Shenzhen Salubris Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College Hospital
  • Chongqing Three Gorges Central Hospital
  • Nanjing Drum Tower Hospital
  • Zhongda Hospital, Southeast University
  • Huadong Hospital Affiliated to Fudan University
  • Shanghai Sixth People's Hospital
  • The West China Second UniversityHospital of Sichuan University
  • West China Hospital,Sichuan University
  • Tianjin Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

rhPTH(1-34) 28.2μg

rhPTH(1-34) 56.5μg

teriparatide acetate(Teribone™)

Arm Description

Participants received 28.2μg rhPTH(1-34)administered by subcutaneous injection once a week for 24 weeks.

Participants received 56.5μg rhPTH(1-34)administered by subcutaneous injection once a week for 24 weeks.

Participants received 56.5μg teriparatide acetate(Teribone™) administered by subcutaneous injection once a week for 24 weeks.

Outcomes

Primary Outcome Measures

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)

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

Full Information

First Posted
October 14, 2018
Last Updated
October 23, 2018
Sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03720886
Brief Title
G56W1 in Women With Postmenopausal Osteoporosis
Official Title
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
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rhPTH(1-34) 28.2μg
Arm Type
Experimental
Arm Description
Participants received 28.2μg rhPTH(1-34)administered by subcutaneous injection once a week for 24 weeks.
Arm Title
rhPTH(1-34) 56.5μg
Arm Type
Experimental
Arm Description
Participants received 56.5μg rhPTH(1-34)administered by subcutaneous injection once a week for 24 weeks.
Arm Title
teriparatide acetate(Teribone™)
Arm Type
Active Comparator
Arm Description
Participants received 56.5μg teriparatide acetate(Teribone™) administered by subcutaneous injection once a week for 24 weeks.
Intervention Type
Biological
Intervention Name(s)
rhPTH(1-34) 28.2μg
Other Intervention Name(s)
G56W1
Intervention Description
Administered by subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
rhPTH(1-34) 56.5μg
Other Intervention Name(s)
G56W1
Intervention Description
Administered by subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
teriparatide acetate(Teribone™)
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
The percentage change in bone density of the lumbar spine ( L1-4 ) from baseline to 24 weeks after treatment
Description
bone mineral density(BMD) measured by dual energy x-ray absorptiometry (DXA)
Time Frame
Baseline,week 24
Secondary Outcome Measure Information:
Title
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
Description
Central lab will be used
Time Frame
Baseline,week 24
Title
The percentage change of total hip bone density from baseline to 24 weeks after G56W1 treatment
Description
BMD measured by DXA
Time Frame
Baseline,week 24
Title
Maximum plasma concentration (Cmax)
Description
serum parathyroid hormone(PTH) will be tested for all pharmacokinetics parameters
Time Frame
Baseline,week 1,week 4,week 12,week 24
Title
Area under the plasma concentration versus time curve (AUC)
Description
serum PTH will be tested for all pharmacokinetics parameters
Time Frame
Baseline,week 1,week 4,week 12,week 24
Title
Time to maximum plasma concentration(Tmax)
Description
serum PTH will be tested for all pharmacokinetics parameters
Time Frame
Baseline,week 1,week 4,week 12,week 24
Title
Elimination half-life(t1/2)
Description
serum PTH will be tested for all pharmacokinetics parameters
Time Frame
Baseline,week 1,week 4,week 12,week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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< -1.0. 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. 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) . Alkaline phosphatase(ALP)>1.5 times the upper limit of normal. Aspartate transaminase(AST) or alanine aminotransferase(ALT) or total bilirubin(TBIL) > 2.0 times the upper limit of normal. Glycated hemoglobin(HbA1c )≥ 7.0% . White blood cell(WBC)< 3.5×10^9 /L , Hb<100g/L or Plt<90×10^9 /L. Thyroid-stimulating hormone(TSH)<0.01 mIU/L (mU/L) or TSH>10 mIU/L (mU/L) . Parathyroid hormone(PTH)>1.5 times the upper limit of normal. Serum creatinine(SCr)>1.2 times the upper limit of normal. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weibo Xia, Prof.
Organizational Affiliation
Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100006
Country
China
Facility Name
Chongqing Three Gorges Central Hospital
City
Wanzhou
State/Province
Chongqing
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Zhongda Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Huadong Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The West China Second UniversityHospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Tianjin Hospital
City
Tianjin
State/Province
Tianjin
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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G56W1 in Women With Postmenopausal Osteoporosis

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