CTRI/2023/09/057671已完成3 期
A multi-center, randomized, double blind, parallel group, phase III study to evaluate efficacy, safety, and immunogenicity of Lupin’s Denosumab (IRO2201A/LUBT014) in comparison with Prolia® in postmenopausal women with osteoporosis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 12
- 主要终点
- Percent change from baseline in Bone Mineral Density (BMD) at the lumbar spine at Month 12.
研究概览
简要总结
A multi-center, randomized, double blind, parallel group, phase III study to evaluate efficacy, safety, and immunogenicity of Lupin’s Denosumab (IRO2201A/LUBT014) in comparison with Prolia® in postmenopausal women with osteoporosis. Approximately 150 patients are planned to be enrolled in the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 55.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Postmenopausal women with osteoporosis.
- •A woman is considered postmenopausal if she meets any of the following criteria: • Lack of menstrual period for at least 12 months prior to screening, for which there is no other pathological or physiological cause.
- •â€¢ Have had surgical bilateral oophorectomy (with or without hysterectomy) at least six months ago.
- •(Serum follicle stimulating hormone [FSH] and serum estradiol level tests can be done at screening in case of uncertainty.)
- •Age ≥ 55 and ≤ 80 years at the time of informed consent.
- •Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar spine as measured by Dual-energy X-ray absorptiometry (DXA).
- •At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA.
- •Patients willing to provide written informed consent.
排除标准
- •Body weight of ≤ 45 kg and ≥ 95 kg at screening.
- •Presence of one severe or more than two moderate vertebral fractures as determined by spine X-ray during the screening period.
- •Inadequate renal function at the screening defined as patient on dialysis or estimated glomerular filtration rate (eGFR) < 30 mL/min.
- •Presence of clinically significant leukopenia, neutropenia, or anaemias judged by the investigator.
- •Prior denosumab and strontium or fluoride administration.
- •Ongoing and/or prior administration of the following medicines for osteoporosis: a.
- •Intravenous bisphosphonates: dose received within 5 years prior to screening.
- •Oral bisphosphonates used > 3 years cumulative use, and any dose within 12 months of screening.
- •Teriparatide or any parathyroid hormones (PTH) analogues: dose received within 6 weeks prior to screening.
- •Tibolone, oral, or topical (e.g., transdermal, intravaginal) estrogen, selective estrogen receptor modulators (SERMs): dose received within 6 weeks prior to screening.
- •Calcitonin: dose received within 6 weeks prior to screening.
- •Active Vitamin D dose received within 2 weeks prior to screening.
- •Systemic glucocorticosteroids (≥ 5 mg prednisone equivalent per day for ≥ 10 days or a total cumulative dose of ≥ 50 mg) within the past 3 months before screening.
- •Other bone active drugs (i.e., drugs affecting bone metabolism) including heparin, anti-epileptics (except for benzodiazepines and pregabalin), systemic ketoconazole, adrenocorticotrophic hormone (ACTH), lithium, protease inhibitors, gonadotropinreleasing hormone (GnRH) agonists, or anabolic steroids within the past 3 months prior to screening.
- •Receiving or has received any investigational drug (or is currently using an investigational device) within 3 months before receiving IMP, or at least 10 times the respective elimination half-life (whichever period is longer).
- •Abnormal serum calcium (re-test and rescreening is permitted): current hypocalcemia (< 8.4 mg/dL).
- •Vitamin D deficiency (25-hydroxy vitamin D levels cut-off at < 12 ng/mL) at screening.
- •(Vitamin D repletion/re-test and rescreening is permitted).
- •History and/or presence of following bone conditions: bone metastases, renal osteodystrophy, Paget’s disease, osteogenesis imperfect, osteopetrosis, osteomyelitis, Pott’s disease (tuberculosis of spine), Cushing’s syndrome.
- •Current or prior use of romosozumab or antisclerostin antibody.
- •Current hypoparathyroidism or hyperparathyroidism other than clinically not significant secondary hyperparathyroidism as judged by the investigator.
- •Major surgery within 8 weeks before screening or planned, anticipated major surgery during the study.
- •History and/or presence of malignancy (except completely cured in situ cervical carcinoma or non-metastatic squamous or basal cell carcinoma of the skin).
- •History and/or presence of significant cardiac disease as judged by the investigator.
- •Known intolerance to or malabsorption of calcium or Vitamin D.
- •Known hypersensitivity of monoclonal antibodies or history of systemic hypersensitivity to any component of the IMPs.
- •Contraindications to denosumab therapy (e.g., hypocalcaemia), or calcium or vitamin D supplementation before starting the IMP administration.
- •Known allergic reactions, hypersensitivity, or intolerance to denosumab or to any ingredients of the IMP, including latex allergy.
- •Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal, and/or pre-existing dental disease as assessed by the Investigator.
- •Any other clinically significant disorder/condition/disease or lab abnormality that in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
结局指标
主要结局
Percent change from baseline in Bone Mineral Density (BMD) at the lumbar spine at Month 12.
时间窗: 12 months
Note: L1-L4 region should be included.
时间窗: 12 months
次要结局
- 1 Efficacy Endpoints(Percent change from baseline in BMD at the lumbar spine at Month 6)
研究者
研究点 (12)
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