Back to resultsEfficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk
Primary Purpose
Postmenopausal Osteoporosis
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
QL1206
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
-
Sites / Locations
- Shanghai sixth people's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
QL1206
Placebo
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months
BMD is the amount of bone mineral in bone tissue. BMD scan was done using 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 calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value
Percent change in BMD at the total hip, femoral neck and trochanter from Baseline up to 6 months and 12 months
Percent change in BMD at the total hip, femoral neck and trochanter as measured BMD is the amount of bone mineral in bone tissue. BMD scan was done using 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 calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value.
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
s-CTX is biomarker of bone resorption and formation. s-CTX was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100.
s-PINP is biomarker of bone resorption and formation. s-PINP was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100
Adverse events and serious adverse events
Evaluation of the follwing parameters. Including adverse events(AEs), change in physical examination findings, change in vital signs, clinical laboratory testing for systemic safety,including liver function,renal function ,compelete blood count,and clinical chemistries
Immunogenicity
Anti-denosumab antibody formation was assessed. Binding antibody and neutralizing antibody assays were used to assess number of participants with anti-denosumab antibody.
Full Information
NCT ID
NCT04128163
First Posted
September 25, 2019
Last Updated
November 5, 2019
Sponsor
Qilu Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04128163
Brief Title
Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk
Official Title
A Twelve-month Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of QL1206 in Chinese Postmenopausal Women With Osteoporosis at High Risk of Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
This is a randomized, double-blind, two-group parallel, placebo-controlled clinical Phase III trial.
The primary objective is to evaluate the effect of QL1206 treatment compared with placebo in Chinese postmenopausal women with osteoporosis at high risk of fracture.
The secondary objective is to evaluate the clinical safety, immunogenicity and pharmacokinetic (PK) characteristics of QL1206 in women with osteoporosis at high risk of postmenopausal fracture
The exploratory purpose is to evaluate the effect of ADA on the characteristics of QL1206 PK and the relationship between QL1206 exposure and pharmacodynamic endpoints, efficacy and adverse events
Subjects would sequentially enrolled according to the protocol in one of two cohorts.Subjects would receive a single 60mg of QL1206 or placebo every 6 month for1 year(twice for one, subcutaneous injection) ,meanwhile taking 500 mg of calcium and 1000IU of vitamin D daily
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
440 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QL1206
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
QL1206
Other Intervention Name(s)
Recombinant anti-RANKL human monoclonal antibody injection
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
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
Primary Outcome Measure Information:
Title
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months
Description
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.
Time Frame
Baseline and Month 12
Secondary Outcome Measure Information:
Title
Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months
Description
BMD is the amount of bone mineral in bone tissue. BMD scan was done using 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 calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value
Time Frame
Baseline and Month 6
Title
Percent change in BMD at the total hip, femoral neck and trochanter from Baseline up to 6 months and 12 months
Description
Percent change in BMD at the total hip, femoral neck and trochanter as measured BMD is the amount of bone mineral in bone tissue. BMD scan was done using 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 calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value.
Time Frame
Baseline 、 Month 6 and Month 12
Title
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
Description
s-CTX is biomarker of bone resorption and formation. s-CTX was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100.
s-PINP is biomarker of bone resorption and formation. s-PINP was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100
Time Frame
Baseline 、 Month 6 and Month 12
Title
Adverse events and serious adverse events
Description
Evaluation of the follwing parameters. Including adverse events(AEs), change in physical examination findings, change in vital signs, clinical laboratory testing for systemic safety,including liver function,renal function ,compelete blood count,and clinical chemistries
Time Frame
Baseline、 Month 1、 Month 3、 Month 6 、 Month 9 and Month 12
Title
Immunogenicity
Description
Anti-denosumab antibody formation was assessed. Binding antibody and neutralizing antibody assays were used to assess number of participants with anti-denosumab antibody.
Time Frame
Baseline、 Month 3、 Month 6 、 Month 9 and Month 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shunjiang yu, CMO
Phone
0531-83129659
Email
shunjiang.yu@qilu-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhenlin zhang
Organizational Affiliation
Shanghai 6th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai sixth people's hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhenlin zhang
First Name & Middle Initial & Last Name & Degree
zhenlin zhang
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk
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