Postmenopausal Osteoporosis
Conditions
Brief summary
A multicenter, randomized, double-blind, placebo-controlled phase III clinical study will be conducted to evaluate the efficacy and safety of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture, as well as an exploratory population pharmacokinetic analysis of LY06006.
Detailed description
It is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. Primary Objective: To evaluate the efficacy of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture. Secondary Objectives: To evaluate the safety of LY06006. To evaluate the immunogenicity of LY06006. Population pharmacokinetic analysis of LY06006.
Interventions
DRUGLY06006
60 mg/1 ml, once every 6 months administered subcutaneously, two injections in total
Sponsors
Shang Dong Boan Biotechnology Co., Ltd (Co-sponsor)
Luye Pharma Group Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator)
Intervention model description
It is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Postmenopausal woman, ages ≥50 to ≤85 years.≥3 years postmenopausal, which can be≥3 years of spontaneous amenorrhea or ≥3 years post-surgical bilateral oophorectomy. If \< 60 years of age and had hysterectomy but ovarian retention, require follicle stimulating hormone (FSH) levels ≥40U/L.
Exclusion criteria
2. Low BMD (BMD absolute value consistent with a T-score≤-2.5 and \>-4.0 at either the lumbar spine or total hip). The BMD equivalents by T-score thresholds for each DXA scanner manufacturer are provided below. 3. Have at least one of the following risk factors: 1. history of fragility fracture 2. parental history of hip fracture 3. low body weight (BMI≤19kg/m2) 4. elderly (age≥65y) 5. current smoker 4. Voluntarily signed written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine | Baseline and Month 12 | Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Changes in total hip BMD | Baseline,Month 6 and Month 12 | Percent Changes in total hip BMD from baseline at 6 and 12 months of treatment |
| Percent Changes in femoral neck BMD | Baseline,Month 6 and Month 12 | Percent Changes in femoral neck BMD from baseline at 6 and 12 months of treatment |
| Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine | Baseline and Month 6 | Percent Change From Baseline in BMD at the Lumbar Spine at Month 6 |
| Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline | Baseline, Month 1, Month 6 and Month 12 | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1, Month 6, and Month 12 |
| Percent Change in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline | Baseline, Month 1, Month 6 and Month 12 | Percent Change From Baseline in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline at Month 1, Month 6, and Month 12 |
| Percent Changes in trochanteric BMD | Baseline,Month 6 and Month 12 | Percent Changes in trochanteric BMD from baseline at 6 and 12 months of treatment |
Countries
China
Contacts
Primary ContactZhenlin Zhang, doctor
Backup ContactJiemei Gu, doctor
Outcome results
None listed