Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk

NCT04128163 | Unknown Phase 3

• 1 other identifier: QL1206-004
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, two-group parallel, placebo-controlled clinical Phase III trial to compare the efficacy and safety of QL1206 and placebo in postmenopausal women with osteoporosis at high risk of fracture

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months

  Bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD scan was done using dual energy x-ray absorptiometry (DXA). It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calcuated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. The analysis was performed by Analysis of Covariance (ANCOVA) model adjusted for treatment, region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as Baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the Last Observation Carried Forward (LOCF), provided the assessment was taken on or after at least three month on-therapy.

  Baseline and Month 12

Secondary Outcomes (5)

• Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months

  Baseline and Month 6

• Percent change in BMD at the total hip, femoral neck and trochanter from Baseline up to 6 months and 12 months

  Baseline 、 Month 6 and Month 12

• Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type I N Propeptideserum (s-PINP) from Baseline up to 6 months and 12 months

  Baseline 、 Month 6 and Month 12

• Adverse events and serious adverse events

  Baseline、 Month 1、 Month 3、 Month 6 、 Month 9 and Month 12

• Immunogenicity

  Baseline、 Month 3、 Month 6 、 Month 9 and Month 12

Study Arms (2)

QL1206

EXPERIMENTAL

QL1206 injection (60mg:1ml) by subcutaneous injectionevery 6 month for two times. Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU

Drug: QL1206

Placebo

PLACEBO COMPARATOR

placebo injection (1ml) by subcutaneous injectionevery 6 month for two times. Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU

Drug: Placebos

Interventions

QL1206 DRUG

subcutaneous injection of 60 mg（60mg:1ml）, Q6M, twice for one year. Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU

Also known as: Recombinant anti-RANKL human monoclonal antibody injection

QL1206

Placebos DRUG

subcutaneous injection of（1ml）, Q6M, twice for one year. Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject is willing to provide written informed consent.
• Ambulatory woman between the age of 50 and 85 years, inclusive.
• The subject has a BMD absolute value consistent with a T-score\<-2.5 and \>-4.0 at either the lumbar spine or total hip
• All subjects must have at least one of following additional the risk factors:history of fracture（after 40 years）,parental history of hip fracture, low Body mass index (BMI≤19kg/m\^2), elderly (age≥65year)，current smoker
• Postmenopausal defined as \>2 years postmenopausal, which can be \>2 years of spontaneous amenorrhea or \>2 years post surgical bilateral oophorectomy.

You may not qualify if:

• Bone/metabolic disease:a. Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,which may interfere with the interpretation of the findings.
• b. Paget's disease c. Cushing's disease d. Hyperprolactinemia
• Current hyperparathyroidism or hypoparathyroidism by medical record
• Thyroid condition: Hyperthyroidism or hypothyroidism.
• Rheumatoid arthritis

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai sixth people's hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

QL1206

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• zhenlin zhang

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shunjiang yu, CMO

CONTACT

0531-83129659; shunjiang.yu@qilu-pharma.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: September 25, 2019
• First Posted: October 16, 2019
• Study Start: June 5, 2019
• Primary Completion: August 31, 2021
• Study Completion: December 1, 2021
• Last Updated: November 6, 2019

Record last verified: 2019-09

Locations

CN (1)