Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .

NCT04591275 | Completed Phase 3

• 1 other identifier: CMAB807-III-001
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief Summary

evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• BMD percentage change from baseline at lumbar spine(L1~L4)

  Percentage change from baseline at lumbar spine(L1\~L4) by dual-energy X-ray absorptiometry to month 12 of treatment and compare between two arms. Percentage change of lumbar spine BMD from baseline to at month 12 of treatment=(BMD at month 12 of treatment - BMD at baseline)/BMD at baseline\*100%

  baseline, at 12 months

Secondary Outcomes (7)

• BMD percentage change from baseline at lumbar spine(L1~L4)

  baseline, at 6 months

• BMD percentage change from baseline at total hip, trochanter and femoral neck

  baseline, at month 6, at month 12

• Serum CTX1 and P1NP concentration percentage change from baseline

  baseline, at month 1, at month 3, at month 6, at month 9,and at month 12

• Proporation of new osteoporotic fractures(vertebrae, total hip and non-vertebrae) occurring within the study period

  baseline, at month 12

• Adeverse events and serious adverse events

  baseline ,at 12 months

Study Arms (2)

CMAB807

EXPERIMENTAL

60mg, every 6 months, subcutaneously for twice. dietary supplement: elemental calcium orally, 600mg, daily, and vitamin D orally, 400IU, daily

Drug: CMAB807 Injection

Prolia®

ACTIVE COMPARATOR

60mg, every 6 months, subcutaneously for twice. dietary supplement: elemental calcium orally, 600mg, daily, and vitamin D orally, 400IU, daily

Drug: Prolia®

Interventions

CMAB807 Injection DRUG

mAb targeting RANKL, human monoclonal antibody targeting RANKL

Also known as: Denosumab Injection

CMAB807

Prolia® DRUG

mAb targeting RANKL, human monoclonal antibody targeting RANKL

Also known as: Denosumab Injection

Prolia®

Eligibility Criteria

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

You may qualify if:

• Fully informed, understood, voluntary participate, and the patient himself or guardian agree to sign the written informed consent and patient be able to comply with the protocol;
• Aged from 50 years to 85 years, inclusive;
• Spontaneous amenorrhea time ≥ 2 years, or bilateral oophorectomy≥ 2 years. If the status of bilateral ovariectomies is unknown, the menopause status should be confirmed by follicle stimulating hormone(FSH) level≥ 40IU/L;
• Based on the results of dual energy X-ray absorptiometry, BMD of lumbar spine(L1\~L4), femoral neck or total hip: -4.0\<T-Score≤-2.5；
• There must be at least one of the following risk factors:
• History of osteoporotic fracture;
• Father's and mother's hip fracture history, or both parents';
• Low body mass index(≤19kg/m\^2);
• Patient's age was equal or greater than 70 years old;
• Current smoker;
• CTX1 was one standard deviation higher than that of healthy premenopausal women within screening period(ie, CTX1\>0.43ng/mL);
• Ability to act independently.

You may not qualify if:

• Suffering from the following diseases known to affect calcium or bone metabolism:
• Various metabolic bone diseases, such as osteogenesis imperfecta and osteomalacia;
• Paget's osteopathy;
• Cushing's syndrome;
• Hyperprolactinemia;
• Hypopituitarism;
• Acromegaly;
• History of hyperparathyroidism or hypoparathyroidism;
• History of hyperthyroidism or hypothyroidism(hypothyroidism patients can be included: only receiving stable thyroid hormone replacement therapy, if the thyroid stimulating hormone(TSH) level is normal, or 5.5μIU/mL\<TSH≤10.0μIU/mL, and free thyroxine(FT4) is in normal range can be included);
• Malabsorption syndrome or various gastrointestinal diseases associated with malabsorption, such as Crohn's disease and chronic pancreatitis;
• Abnormal level of blood calcium: the current diagnosis of hypocalcemia or hypercalcemia or albumin corrected serum calcium levels are not within the laboratory normal range(calcium supplements should not be used for at least 8 hours prior to serum calcium testing);
• Vitamin D deficiency: 25 hydroxyvitamin D concentration\<20ng/mL. Allowed to retest after oral vitamin D2 soft capsules in the screening period. If the concentration of 25 hydroxyvitamin D is more than or equal to 20ng/mL， it can be selected;
• Other diseases such as rheumatoid arthritis, gout, multiple myeloma, etc;
• Medical history of two or more vertebrae fractures;
• Malignant tumor(excluding skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ or breast ductal carcinoma in situ) in recent 5 years;

Sponsors & Collaborators

• Shanghai Biomabs Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hosptial

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Denosumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• weibo Xia, Doctor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

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: October 15, 2020
• First Posted: October 19, 2020
• Study Start: March 31, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 20, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)