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G56W1 in Women With Postmenopausal Osteoporosis

NCT03720886 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2018-10-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shenzhen Salubris Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Weibo Xia, Prof. · Peking Union Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-05-31
Completion
2020-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03720886 on ClinicalTrials.gov