ClinicalTrialsFinder
RecruitingPhase 3NCT07062978

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

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

Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

278 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

Postmenopausal Women With Osteoporosis at High Risk of Fracture

Summary

This study is 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.

Eligibility

Sex: FEMALEMin Age: 50 YearsMax Age: 85 Years

Inclusion Criteria5

  • 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 Criteria14

  • 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.
Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGQL1206

QL1206 Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.

DRUGProlia®

Prolia® Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.

Locations(1)

Zhejiang Provincial People's Hospital Bijie Hospital

Guizhou, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07062978