Postmenopausal Women With Osteoporosis study: SAL056 vs Intervention Group
Official title A Phase II Clinical Trial of the Safety and Efficacy of SAL056 at Different Doses and Dosing Regimens
ClinicalTrials.gov ID: NCT07579936
What this study is testing
What is SAL056 56.5μg?
An investigational once‑weekly injectable medicine being studied for postmenopausal osteoporosis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares the safety of four dosing regimens of SAL056.
- Who it's for
- Postmenopausal women who have osteoporosis.
- What's involved
- Participants are randomly assigned to one of four dosing schedules and receive SAL056. They attend clinic visits for safety monitoring and related tests.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 80, women only
You may be able to join if
- 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...
You likely can't join if
- 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...
- Patients with other diseases affecting calcium or bone metabolism, including hyperparathyroidism or hypoparathyroidism, hyperthyroidism or...
- Patients who require treatment with other anti-osteoporosis drugs during the trial or long-term/continuous use of digitalis glycosides such as...
- Patients with severe renal disease (serum creatinine \>1.5 times the upper limit of normal), uncontrolled hypertension [systolic blood pressure ≥160...
- Patients with esophageal abnormalities that cause delayed esophageal emptying (such as reflux esophagitis, esophageal stricture or achalasia) or...
See the full eligibility 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)
- 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...
- Patients with other diseases affecting calcium or bone metabolism, including hyperparathyroidism or hypoparathyroidism, hyperthyroidism or hypothyroidism (patients with hyperthyroidism or hypothyroidism receiving stable...
- 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...
- Patients with esophageal abnormalities that cause delayed esophageal emptying (such as reflux esophagitis, esophageal stricture or achalasia) or those with difficulty swallowing;
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beijing, Beijing Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.