EUCTR2020-005548-48-BG进行中（未招募）1 期
A Randomized, Double-Blind, Multinational, Multicenter Study to Compare Efficacy, Safety, and Immunogenicity of TVB-009P and Denosumab (PROLIA®) in Patients with Postmenopausal Osteoporosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 326
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Patients may be included in this study only if they meet all of the following criteria:
- •a. The patient provides a signed and dated written informed consent.
- •b. The patient is a clinically stable, ambulatory, female postmenopausal adult (=60 and =90 years) with a diagnosis of osteoporosis.
- •c. The patient is of postmenopausal status, defined as: Spontaneous amenorrhea for >12 months, or Spontaneous amenorrhea >6 months and serum follicle stimulating hormone
- •(FSH) and estradiol (E2) in menopausal range, or
- •Surgical menopause at least 6 weeks before the start of screening.
- •d. The patient has a body weight =50 kg and =90 kg (=110 lb and =198 lb) at screening.
- •e. The patient agrees to be supplemented with 1000 mg calcium and at least 400 IU vitamin D daily from screening until the last visit.
- •f. The patient has a BMD-measurement T-score of less than -2.5 but not less than -4.0 by dual energy X-ray absorptiometry (DXA) at the lumbar spine at screening based on central reader assessment.
- •g. The patient has at least three (3) vertebrae in the L1-L4 region that are evaluable by DXA.
- •h. The patient has serum 25 (OH) vitamin D level >20 ng/mL at screening and no current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory. Vitamin D and calcium supplements will be provided and patients may be rescreened once to re-evaluate calcium and/or vitamin D level post repletion.
- •i. The patient must be willing and able to comply with study restrictions and to remain
- •at the investigational center for the required duration during the study period, and willing to return to the investigational center for further visits, as applicable, and the follow-up procedures and assessments as specified in this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 261
排除标准
- •Patients will be excluded from participating in this study if they meet any of the following
- •a. The patient has a known malabsorption of calcium or vitamin D supplements.
- •b. The patient has a metabolic or bone disease (except osteoporosis) such as Paget’s disease, Cushing’s disease, rheumatoid arthritis, sclerosteosis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, hyperprolactinemia, malabsorption syndrome, osteomyelitis, multiple myeloma or related lymphoproliferative disorder, or bone metastases.
- •c. The patient has a current, uncontrolled hyperthyroidism or hypothyroidism, per
- •patient report or chart review.
- •d. The patient has hypoparathyroidism or hyperparathyroidism (irrespective of current
- •controlled or uncontrolled status).
- •e. The patient has a history and/or presence of risk factors of osteonecrosis of the jaw, as
- •determined by the principal investigator, (eg, unhealed open soft tissue lesions in the mouth, poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, recent or planned invasive dental procedures such as tooth extractions within the next 18 months), presence of anemia or coagulopathy at screening, and/or inability to maintain oral hygiene during the study.
- •f. The patient has a history and/or presence of 1 severe or more than 2 moderate vertebral fractures (as determined by central reading of lateral spine X-ray during the screening period).
- •g. The patient has a history and/or presence of hip fracture or atypical femur fracture.
- •h. The patient has participated in another study of an IMP (or a medical device) within
- •the previous 30 days or 5 half-lives of the IMP (whichever is longer) or longer if required by local regulations, or is currently participating in another study of an IMP (or a medical device).
- •i. The patient has a known hypersensitivity to any components of the IMPs stated in this
- •protocol or to calcium or vitamin D.
- •j. The patient has a renal impairment manifested with an estimated glomerular filtration rate (eGFR) <45 mL/min.
- •k. The patient has cardiac disease as per investigator's discretion, including electrocardiogram (ECG) abnormalities at screening indicating significant risk of safety for patients participating in the study.
- •l. The patient has a malignancy or past malignancy (except for local non-melanoma
- •skin cancer fully resected).
- •m. The patient has a current skin infection(s).
- •n. The patient has infectious disease:
- •- Acute infection and/or antibiotic treatment must be resolved 28 days prior to the first dose of IMP.
- •- Any relevant chronic infection. Ongoing hepatitis B, hepatitis C, human immunodeficiency virus (HIV) Types 1 or 2 infection.
- •- Positive test for coronavirus disease 2019 (COVID-19) during screening or patient reporting a recent history of confirmed COVID-19 which had not fully recovered more than 14 days before screening.
- •o. The patient has any medical condition that (treated or untreated), in the opinion of the
- •investigator, could jeopardize or would compromise the patient’s safety or ability to
- •participate in this study.
- •p. The patient has had any prior treatment with denosumab (PROLIA or XGEVA or biosimilars of denosumab products).
- •q. The patient has used intravenous bisphosphonates within less than 5 years prior to screening.
- •r. The patient has used oral bisphosphonates within the 12 months prior to start of screening and/or cumulative use >3 years before the start of screening.
- •s. The patient has ong
研究者
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