Status:
COMPLETED
Efficacy and Safety of MW031 in PMO Subjects
Lead Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
55-80 years
Phase:
PHASE3
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 subjec...
Eligibility Criteria
Inclusion
- 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
- Bone/metabolic disease
- Hyperparathyroidism or hypoparathyroidism
- Thyroid condition: Hyperthyroidism or hypothyroidism
- Rheumatoid arthritis
- Malignant tumors
- Malabsorption syndrome
- Oral bisphosphonates
Key Trial Info
Start Date :
December 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2021
Estimated Enrollment :
448 Patients enrolled
Trial Details
Trial ID
NCT05215977
Start Date
December 27 2019
End Date
September 27 2021
Last Update
October 11 2023
Active Locations (1)
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1
Peking Union Hospital
Beijing, Beijing Municipality, China, 100000