New osteoporosis shot aims to strengthen bones in older women
NCT ID NCT07579936
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called SAL056 in postmenopausal women with osteoporosis. The goal is to find the safest and most effective dose. About 200 women aged 45 to 80 will receive different doses of the drug or a control treatment for around 10 weeks. The study focuses on side effects and how well the drug works to strengthen bones.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2026
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
45 to 80 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1.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: 1. Received teriparatide treatment within 1 month prior to screening; 2. 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.; 3. 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.; 4. Patients who require treatment with other anti-osteoporosis drugs during the trial or long-term/continuous use of digitalis glycosides such as digoxin; 5. 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; 6. Patients with esophageal abnormalities that cause delayed esophageal emptying (such as reflux esophagitis, esophageal stricture or achalasia) or those with difficulty swallowing; 7. Abnormal laboratory findings detected during the screening period, including any of the following abnormal indicators: 1\) Alkaline phosphatase \>1.3 times the upper limit of normal; 2) Alanine aminotransferase or aspartate aminotransferase \>3.0 times the upper limit of normal; 3)Total bilirubin \>1.5 times the upper limit of normal; 4) Glycated hemoglobin ≥8.5%; 5)White blood cell count \<3.0×10⁹/L, or hemoglobin \<100g/L, or platelet count \<90×10⁹/L; 6)Parathyroid hormone \>1.5 times the upper limit of normal; 8. Positive for hepatitis C virus antibody, or Treponema pallidum antibody, or human immunodeficiency virus antibody; or positive for hepatitis B surface antigen (HBsAg) with peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer ≥1×103 copies/mL (if HBsAg is positive and peripheral blood HBV DNA titer \<1×103 copies/mL, the trial participant is eligible if the investigator considers the participant's chronic hepatitis B to be in a stable phase and will not increase the risk to the trial participant); 9. History of major surgery (excluding fracture surgery) within 6 months prior to signing the informed consent form, or planned major surgery during the study period; 10. Known history of organ transplantation; 11. History of drug abuse within 6 months prior to informed consent; 12. Individuals with known allergy to the investigational drug; 13. Patients who have previously received radiation therapy to the skeletal system; 14. Individuals with mental illness or cognitive impairment due to any cause; 15. Patients deemed unsuitable to participate in this study by researchers based on risk-benefit considerations.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Osteoporosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Peking University Third Hospital
RECRUITINGBeijing, Beijing Municipality, 230088, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Pregnancy hormone hCG may hold clues to bone and gland health
- Simple scan mistakes may skew osteoporosis diagnoses
- Can better posture strengthen the pelvic floor in osteoporosis?
- Could exercise be the key to stronger bones in women?
- Robotic legs may help rebuild bone in people with spinal cord injury
- Could a simple education program stop the cycle of fractures in the elderly?