RecruitingPhase 2

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

China200 participantsStarted 2026-04-30

Plain-language summary

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.

Who can participate

Age range

45 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

.Female, with independent mobility, 45 years ≤ age ≤ 80 years; 2.Natural menopause for ≥3 years, or surgical menopause for ≥3 years (surgery must be performed after age 40); for women with surgical menopause, follicle-stimulating hormone \>40 mIU/mL is required; 3.18 ≤ body mass index ≤ 30 kg/m²; 4.Previous definitive diagnosis of osteoporosis; 5.Patients who are able to independently go to the hospital to receive injections of the investigational drug; 6. Voluntarily participate in this trial and sign the informed consent form.

Exclusion criteria

. Received teriparatide treatment within 1 month prior to screening;
. Patients with secondary osteoporosis, such as Cushing's syndrome, hyperprolactinemia, malabsorption syndrome or various gastrointestinal diseases related to malabsorption (such as Crohn's disease, chronic pancreatitis, etc.), rheumatoid arthritis, gout, multiple myeloma, etc.;
. Patients with other diseases affecting calcium or bone metabolism, including hyperparathyroidism or hypoparathyroidism, hyperthyroidism or hypothyroidism (patients with hyperthyroidism or hypothyroidism receiving stable treatment with normal hormone levels are eligible; or patients with hypothyroidism where 5.5 mIU/L \< thyroid-stimulating hormone ≤ 10.0 mIU/L but free thyroxine is within normal range are eligible), osteogenesis imperfecta, osteomalacia, Paget's disease of bone, hypercalcemia, hypocalcemia, active urolithiasis, etc.;
. Patients who require treatment with other anti-osteoporosis drugs during the trial or long-term/continuous use of digitalis glycosides such as digoxin;
. Patients with severe renal disease (serum creatinine \>1.5 times the upper limit of normal), uncontrolled hypertension \[systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg\], severe heart disease (such as myocardial infarction, unstable angina pectoris, heart failure with NYHA functional class III-IV, severe arrhythmias, etc.), cerebral infarction (excluding lacunar cerebral infarction) or occlusive arteriosclerosis, malignant tumors, and those with other serious underlying diseases;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The incidence of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) between each intervention group and the control group during the treatment period，about 10weeks

Timeframe: during the treatment period，about 10 weeks

Trial details

NCT IDNCT07579936

SponsorShenzhen Salubris Pharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-30

Contact for this trial

Weishi Li, Professor

13501358705 weishi_li@aliyun.com

View on ClinicalTrials.gov More Postmenopausal Women With Osteoporosis trials