A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®

Launched by QILU PHARMACEUTICAL CO., LTD. · Jul 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well and how safely a new medicine called QL1206 works compared to an existing treatment called Prolia® in women who have osteoporosis after menopause and are at high risk of breaking bones. Osteoporosis is a condition that makes bones weak and more likely to break. The study is looking at women between the ages of 50 and 85 who have low bone density and certain risk factors like past bone fractures, family history of hip fractures, being older (65 or above), low body weight, or smoking.

If you join the study, you will be randomly assigned to receive either QL1206 or Prolia®, but neither you nor the doctors will know which one you get until the study is over. The study is being conducted at multiple locations and is currently recruiting participants. To be eligible, you must be able to walk on your own, have a bone density score within a specific range, and meet other health criteria. Some people won’t be able to join if they have certain health problems like severe kidney issues, some bone or thyroid diseases, recent use of similar bone medicines, or dental problems that require surgery. If you take part, you can expect careful monitoring of your health and bone condition to see how the treatment works and to check for any side effects. This study aims to find out if QL1206 is a safe and effective option for women with osteoporosis who need treatment to help protect their bones.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Subjects who agree to participate in the study and sign the informed consent form.
• • Postmenopausal women who can walk freely, aged 50-85 years (including 50 and 85 years old).
• • Subjects whose absolute value of bone mineral density (BMD) in the lumbar or total hip area meets T values ≤ -2.5 and \> -4.0.
• • Subjects who must have at least one of the following risk factors: History of previous fragility fractures (occurring after the age of 40); history of hip fractures in fathers or mothers; increased bone turnover rate during screening; low body weight (BMI ≤ 19 kg/m2); advanced age (aged ≥ 65 years); current smoke.
• • The duration of spontaneous amenorrhea was \>2 years or \>2 years after bilateral oophorectomy. If the status of bilateral oophorectomy is unknown or if the ovaries are preserved after hysterectomy, follicle stimulating hormone (FSH) levels \>40mIU/mL may be used to confirm the status of postoperative menopause.
• Exclusion Criteria:
• • Bone/metabolic disease.
• • Hyperparathyroidism or hypoparathyroidism.
• • Thyroid condition: Hyperthyroidism or hypothyroidism.
• • Rheumatoid arthritis.
• • Malabsorption syndrome.
• • Renal disease - severe impairment of kidney function.
• • Vitamin D defViciency (25-hydroxyvitamin D, 25OHD \<20 ng/mL).
• • Oral or dental diseases: previous or current evidence of mandibular osteomyelitis or osteonecrosis; Acute dental or mandibular disease requiring oral surgery; Planning invasive dental surgery; Failure to recover from dental or oral surgery.
• • Previously used denosumab drugs.
• • Use of intravenous bisphosphonates, fluoride, or strontium to treat osteoporosis within the last 5 years.
• • OOral bisphosphonates (used for at least 3 years, or used for less than 3 years but more than 3 months, with the last use occurring \<1 year before the ICF).
• • Use of any of the following drugs within 6 weeks prior to screening that may affect bone metabolism.
• • History of more than two vertebral fractures.
• • Malignant tumors.