Actively Recruiting

Phase 2
Age: 45Years - 80Years
FEMALE
NCT07579936

A Phase II Clinical Trial of the Safety and Efficacy of SAL056 at Different Doses and Dosing Regimens

Led by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Updated on 2026-05-12

200

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

S

Shenzhen Salubris Pharmaceuticals Co., Ltd.

Lead Sponsor

S

Salubris (Suzhou) Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a multicenter, randomized, open-label, parallel-controlled Phase II study designed to evaluate the differences in safety among four different dosing regimens of SAL056.

CONDITIONS

Official Title

A Phase II Clinical Trial of the Safety and Efficacy of SAL056 at Different Doses and Dosing Regimens

Who Can Participate

Age: 45Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, independently mobile, aged between 45 and 80 years
  • Natural or surgical menopause for at least 3 years; for surgical menopause after age 40, follicle-stimulating hormone >40 mIU/mL required
  • Body mass index between 18 and 30 kg/m²
  • Previous definitive diagnosis of osteoporosis
  • Ability to independently visit the hospital for injections
  • Voluntary participation and signed informed consent form
Not Eligible

You will not qualify if you...

  • Teriparatide treatment within 1 month before screening
  • Secondary osteoporosis (such as due to Cushing's syndrome, hyperprolactinemia, malabsorption syndromes, rheumatoid arthritis, gout, multiple myeloma)
  • Diseases affecting calcium or bone metabolism including hyperparathyroidism, hypoparathyroidism, unstable thyroid disease, osteogenesis imperfecta, osteomalacia, Paget's disease, hypercalcemia, hypocalcemia, active urolithiasis
  • Requirement for other anti-osteoporosis drugs during the trial or long-term use of digitalis glycosides
  • Severe renal disease, uncontrolled hypertension, severe heart disease, cerebral infarction (excluding lacunar), occlusive arteriosclerosis, malignant tumors, or other serious underlying diseases
  • Esophageal abnormalities causing delayed emptying or difficulty swallowing
  • Abnormal lab findings including elevated alkaline phosphatase, liver enzymes, bilirubin, glycated hemoglobin, low blood counts, or elevated parathyroid hormone
  • Positive for hepatitis C, syphilis, HIV, or hepatitis B with high viral load unless stable chronic hepatitis B
  • Major surgery within 6 months or planned during study
  • History of organ transplantation
  • Drug abuse within 6 months
  • Allergy to the investigational drug
  • Previous radiation therapy to the skeleton
  • Mental illness or cognitive impairment
  • Deemed unsuitable by researchers based on risk-benefit assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University Third Hospital

Beijing, Beijing Municipality, China, 230088

Actively Recruiting

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Research Team

W

Weishi Li, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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