G56W1 in Women With Postmenopausal Osteoporosis

NCT03720886 | Unknown Phase 1

• 1 other identifier: G56W1A201
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 9

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.

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline，week 24

Secondary Outcomes (6)

• 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

• Time to maximum plasma concentration（Tmax）

  Baseline，week 1，week 4，week 12，week 24

Study Arms (3)

rhPTH（1-34） 28.2μg

EXPERIMENTAL

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

Biological: rhPTH（1-34） 28.2μg

rhPTH（1-34） 56.5μg

EXPERIMENTAL

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

Biological: rhPTH（1-34） 56.5μg

teriparatide acetate(Teribone™)

ACTIVE COMPARATOR

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

Biological: teriparatide acetate(Teribone™)

Interventions

rhPTH（1-34） 28.2μg BIOLOGICAL

Administered by subcutaneous injection

Also known as: G56W1

rhPTH（1-34） 28.2μg

rhPTH（1-34） 56.5μg BIOLOGICAL

Administered by subcutaneous injection

Also known as: G56W1

rhPTH（1-34） 56.5μg

teriparatide acetate(Teribone™) BIOLOGICAL

Administered by subcutaneous injection

teriparatide acetate(Teribone™)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (9)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100006, China

Location

Chongqing Three Gorges Central Hospital

Wanzhou, Chongqing Municipality, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Location

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Location

Huadong Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Location

The West China Second UniversityHospital of Sichuan University

Chengdu, Sichuan, China

Location

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Location

Tianjin Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Weibo Xia, Prof.

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 25, 2018
• Study Start: October 1, 2018
• Primary Completion: May 31, 2020
• Study Completion: August 31, 2020
• Last Updated: October 25, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)