Phase 2 Osteoporosis Trial, Recruiting NCT07579936 Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. Condition: Osteoporosis
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Phase 2 Osteoporosis Trial, Recruiting

NCT07579936
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a woman who can move around independently, and you are between 45 and 80 years old
  • Your periods stopped naturally at least 3 years ago, OR you had surgery to remove your ovaries at least 3 years ago (the surgery must have been done after age 40); if your menopause was caused by surgery, a specific hormone level in your blood (FSH) must be above 40 mIU/mL
  • Your body mass index (a measure of weight relative to height) is between 18 and 30
  • You have already been formally diagnosed with osteoporosis
  • You are able to travel to the hospital on your own to receive injections of the study drug
  • You are willing to take part voluntarily and sign a consent form

Who may not be able to join:

  • You received a bone-building medication called teriparatide within the last month
  • Your osteoporosis is caused by another medical condition, such as Cushing's syndrome, certain bowel or digestive diseases (like Crohn's disease or chronic pancreatitis), rheumatoid arthritis, gout, or multiple myeloma, among others
  • You have another condition that affects calcium or bone health, such as parathyroid problems, thyroid problems (unless your condition is well-controlled and stable with normal hormone levels — confirm with trial site), brittle bone disease, softening of the bones, Paget's disease of bone, abnormal calcium levels in the blood, or active kidney stones
  • You need to take other osteoporosis medications during the trial, or you regularly take a heart medication called digoxin
  • You have serious kidney disease, uncontrolled high blood pressure (160/100 mmHg or above), serious heart problems (such as a recent heart attack, unstable chest pain, or significant heart failure), a certain type of stroke (excluding small vessel strokes), blocked arteries, or cancer, or other serious underlying health conditions
  • You have problems with your oesophagus (the tube from your mouth to your stomach) that slow it down, such as reflux disease, narrowing of the oesophagus, or achalasia, or you have difficulty swallowing
  • Your blood test results during the screening period show certain abnormalities, including: liver enzyme or liver function levels that are too high, a blood sugar control measure (HbA1c) of 8.5% or above, low white blood cell count, low haemoglobin (a sign of anaemia), low platelet count, or a parathyroid hormone level that is too high (confirm specific values with trial site)
  • You test positive for Hepatitis C, syphilis, HIV, or you test positive for Hepatitis B with a high level of the virus in your blood (a low level may still be acceptable if a doctor considers your condition stable — confirm with trial site)
  • You had a major operation (not including fracture surgery) in the 6 months before joining, or you are planning a major operation during the study
  • You have previously had an organ transplant
  • You have a history of drug misuse in the past 6 months
  • You are known to be allergic to the study drug
  • You have previously had radiation therapy to your bones or skeleton
  • You have a mental health condition or any problem affecting your memory or thinking
  • The trial doctors decide, for any safety or other reason, that joining would not be appropriate for you

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 13501358705

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Registry
ClinicalTrials.gov
Start date
30 April 2026
Est. completion
30 July 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov