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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    278
  • sponsor
    Shanghai Biomabs Pharmaceutical Co., Ltd.
Updated on 11 August 2021
body mass index
x-rays
prolia
RANKL
osteoporotic fracture
hip fracture
x-ray absorptiometry

Summary

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

Description

this is a randomized, double-blinded, parallel, active-controlled clinical phase III study. the primary objective is to evaluate the efficacy and safety of CMAB807 treatment compared with Prolia in Chinese postmenopausal women with osteoporosis at high risk of fracture.

Subjects should sequentially enrolled according to the protocol in one of two arms. Subjects who entered in test arm would receive 60mg of CMAB807 subcutaneously every 6 months for one year, while those who entered in control arm should receive 60mg of Prolia subcutaneously every 6 months for one year. Meanwhile, every subject should taking 600mg calcium and 400IU vitamin D daily from successfully screening to the end of study.

Details
Condition Osteoporosis, Postmenopausal osteoporosis, Post-Menopausal Osteoporosis, Post-Menopausal Osteopenia
Treatment Prolia®, CMAB807 Injection
Clinical Study IdentifierNCT04591275
SponsorShanghai Biomabs Pharmaceutical Co., Ltd.
Last Modified on11 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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 5.5IU/mL<TSH10.0IU/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
Severe renal function damage(creatinine clearance rate<30mL/min), or dialysis, urinary calculi or chronic cystitis
Suffering from the following liver or biliary diseases
Liver cirrhosis
Biliary abnormalities(except for Gilbert syndrome or asymptomatic gallstones)
Positive hepatitis C virus antibody(HCV-Ab) and the titer of HCV-RNA exceeded the upper limit of norma
Positive hepatitis B suface antigen(HBsAg) and peripheral blood HBV-DNA titer 1000 capies[CPS]/mL or 200IU/mL
Unstable liver disease: defined as liver ascites, hepatic encephalopathy, coagulopathy, hypoalbuminemia, varicosis in esophagus or stomach fundus or persistent hepatic jaundice
Liver transaminase: aspartate aminotransferase2.0upper limit of norma value(ULN), alanine aminotransferase2.0ULN, alkaline phosphatase1.5ULN or total bilirubin1.5ULN
Suffering from the following oral diseases
Osteomyelitis or osteonecrosis of the jaw, previously or currently
Actue dental or mandibular disease requiring stomatological surgery
Planned invasive dental surgery during the trial period
Dental or stomatological surgery have not healed
Conditions which can influence bone mineral density determination by dual energy X-ray
absorptiometry
Less than two lumbar vertebrae can be measured
Height, weight or waistline may hinder accurate measurement
Other conditions that may affect bone density testing
Received anti-osteoporosis drugs or those drugs may affect bone metabolism
Use of injectable bisphosphonates, fluoride or strontium within 2 years before screening
Use of oral bisphosphonates: more than 2 years, or more than 3 months but less than 2 years and discontinued from last dosage less than 1 year, simultaneously
Usage of any drugs which may affect bone metabolism within 6 weeks before screening: parathyroid hormone or parathyroid hormone analogue(such as teriparatide); assimilative hormone or testosterone; glucocorticoid(equivalent to prednisone>5mg/day for more than 10 days); systemic hormone replacement therapy; selective estrogen receptor regulator(such as reloxifene); tibolone; calcitonin; active vitamin D and ite analogues, other bone active drugs include anticonvulsant drugs(except benzodiazepines) and he[arin; long-term systemic use of ketoconazole, androgen, adrenocorticotropic hormone, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin releasing hormone agonist
Patients who have received RANKL inhibitors previously
Positive HIV antibody
Known alcoholism or drug abuse(during 12 months before screening), because alcohol or drug abuse may interfere with subject's understanding or finish of trial
Known allergy to test drug, reference drug or basic drug and its excipients
Participate in interventionary clinical study(drug or device) within one month before screening
Other serious, acute or chronic diseases, mental disorders or laboratory abnormalities, which are judged by investigator to be unsuitable to participate this study
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