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Recruiting NCT07062978

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

Phase III Interventional Postmenopausal Women With Osteoporosis at High Risk of Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QL1206, Prolia®.
Who it may be relevant to
Registry conditions: Postmenopausal Women With Osteoporosis at High Risk of Fracture. Basic parameters: 50 years — 85 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Percent Change From Baseline in lumbar spine(LS)-BMD at Month 12 [Time frame: Baseline and 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhejiang Provincial People's Hospital Bijie Hospital — Guizhou

Identifiers

NCT: NCT07062978 · QL1206-305

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗