Comparing QL1206 with Prolia® for postmenopausal osteoporosis with high fracture risk

A Multicenter, Randomized, Double-blind Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture

This trial will test whether QL1206 works as well and is as safe as Prolia® for postmenopausal women with osteoporosis who are at high risk of fractures.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (estimated)
• Ages: 50 Years to 85 Years
• Sex: Female
• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: denosumab
• Locations: 1 site (Guizhou)
• Trial ID: NCT07062978 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind Phase 3 trial comparing the investigational product QL1206 with Prolia® (denosumab) in postmenopausal women aged 50–85 who have osteoporosis and are at high risk for fracture. Eligible participants have a lumbar or total hip BMD T-score ≤ -2.5 and > -4.0 and must have at least one additional fracture risk factor. Participants will be randomly assigned to receive either QL1206 or Prolia® and followed for clinical safety and bone outcomes including changes in bone mineral density and adverse events. The goal is to determine if QL1206 provides comparable efficacy and safety to the established denosumab treatment.

Who should consider this trial

Good fit: Postmenopausal women aged 50–85 with a lumbar or total hip BMD T-score ≤ -2.5 and > -4.0 who have at least one additional fracture risk factor (for example prior fragility fracture, family history of hip fracture, low BMI, older age, smoking, or elevated bone turnover).

Not a fit: People who are not postmenopausal women, have BMD outside the specified range, have contraindications to denosumab-like therapies, or have excluded metabolic bone disorders are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, QL1206 could provide a treatment option comparable to Prolia® for reducing fracture risk in high-risk postmenopausal women, potentially increasing access or choice.

How similar studies have performed: Denosumab (Prolia®) is an established treatment that reduces fracture risk, and prior biosimilar-comparison trials for biologics have aimed to show similar efficacy and safety, though biosimilar denosumab data are relatively recent.

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.

Where this trial is running

Guizhou

• Zhejiang Provincial People's Hospital Bijie Hospital — Guizhou, China (Recruiting)

Study contacts

• Study coordinator: Youjia Xu

Conditions Postmenopausal Women With Osteoporosis at High Risk of Fracture