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

NCT07062978 | Recruiting Phase 3

• 1 other identifier: QL1206-305
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postmenopausal Women With Osteoporosis at High Risk of Fracture

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in lumbar spine(LS)-BMD at Month 12

  Percent Change From Baseline in lumbar spine(LS)-BMD at Month 12

  Baseline and 12 months

Study Arms (2)

QL1206

EXPERIMENTAL

QL1206 Denosumab injection(60 mg)

Drug: QL1206

Prolia®

ACTIVE COMPARATOR

Prolia® Denosumab injection(60 mg)

Drug: Prolia®

Interventions

QL1206 DRUG

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

QL1206

Prolia® DRUG

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

Prolia®

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhejiang Provincial People's Hospital Bijie Hospital

Guizhou, China

RECRUITING

MeSH Terms

Interventions

QL1206; Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Youjia Xu

CONTACT

+86-0512-67783682; sdfeyec@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

CN (1)