Osteoporosis, Postmenopausal
Conditions
Brief summary
This study is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW031 in Chinese postmenopausal osteoporotic subjects with increased bone fracture risk .
Interventions
DRUGMW031
The active ingredient of MW031 is a recombinant human anti-RANKL monoclonal antibody ,subcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial. Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU
DRUGPlacebo
subcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial. Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* BMD -4.0\<T-score ≤-2.5 at either the lumbar spine or total hip or femoral neck * All subjects must have at least one of following additional the risk factors:history of fracture, parental history of hip fracture, increased bone turnover rate at screening, low body weight, elderly (age≥65year)，current smoker * Postmenopausal is defined as \>2 years postmenopausal, which can be \>2 years of spontaneous amenorrhea, or bilateral oophorectomy \>2 years after surgery. If bilateral oophorectomy status is unknown, use follicle-stimulating hormone (FSH) levels \> 40 mIU/mL to confirm surgical postmenopausal status.
Exclusion criteria
* Bone/metabolic disease * Hyperparathyroidism or hypoparathyroidism * Thyroid condition: Hyperthyroidism or hypothyroidism * Rheumatoid arthritis * Malignant tumors * Malabsorption syndrome * Oral bisphosphonates
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months | Baseline and Month 12 | Dual energy x-ray absorptiometry (DXA) is applied for Bone mineral density (BMD) assessment. |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 12 months | Baseline, Month 1, Month 3, Month 6, Month 9 and Month 12 |
Countries
China
Outcome results
None listed