jRCT2031230117招募中不适用
A multi-center, randomized, double blind, parallel group, phase III study to evaluate efficacy, safety and immunogenicity of Lupins Denosumab in comparison with Prolia in postmenopausal women with osteoporosis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 主要终点
- Percent change from baseline in Bone Mineral Density (BMD) at the lumbar spine
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Double Blind
入排标准
- 年龄范围
- 55age old over 至 80age old under（—）
- 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.
- •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
- •1.Body weight of=<45 kg and>=95 kg at screening.
- •2.Presence of one severe or more than two moderate vertebral fractures as determined by spine X-ray during the screening period.
- •3.Inadequate renal function at the screening defined as patient on dialysis or estimated glomerular filtration rate(eGFR)<30 mL/min.
- •4.Presence of clinically significant leukopenia,neutropenia,or anaemias judged by the investigator.
- •5.Prior denosumab and strontium or fluoride administration.
- •6.Ongoing and/or prior administration of the following medicines for osteoporosis:
- •a.Intravenous bisphosphonates:dose received within 5 years prior to screening.
- •b.Oral bisphosphonates used>3years cumulative use,and any dose within 12 months of screening.
- •c.Teriparatide or any parathyroid hormones(PTH)analogues:dose received within 6 weeks prior to screening.
- •d.Tibolone, oral, or topical(e.g.,transdermal,intravaginal)estrogen,selective estrogen receptor modulators(SERMs):dose received within 6 weeks prior to screening.
- •e.Calcitonin:dose received within 6 weeks prior to screening.
- •f.Active Vitamin D dose received within 2 weeks prior to screening.
- •7.Systemic glucocorticosteroids(>=5mg prednisone equivalent per day for>=10 days or a total cumulative dose of=>50mg)within the past 3 months before screening.
- •8.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, gonadotropin-releasing hormone(GnRH)agonists,or anabolic steroids within the past 3 months prior to screening.
- •9.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).
- •10.Abnormal serum calcium(re-test and rescreening is permitted):current hypocalcemia(< 8.4 mg/dL).
- •11.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).
- •12.History and/or presence of following bone conditions:bone metastases,renal osteodystrophy,Pagets disease,osteogenesis imperfect,osteopetrosis,osteomyelitis,Potts disease(tuberculosis of spine),Cushings syndrome.
- •13.Current or prior use of romosozumab or antisclerostin antibody.
- •14.Current hypoparathyroidism or hyperparathyroidism other than clinically not significant secondary hyperparathyroidism as judged by the investigator.
- •15.Major surgery within 8 weeks before screening or planned, anticipated major surgery during the study.
- •16.History and/or presence of malignancy(except completely cured in situ cervical carcinoma or non-metastatic squamous or basal cell carcinoma of the skin).Patient with history of malignancy without recurrence for more than 5 years can be included.
- •17.History and/or presence of significant cardiac disease as judged by the investigator.
- •18.Known intolerance to or malabsorption of calcium or Vitamin D.
- •19.Known hypersensitivity of monoclonal antibodies or history of systemic hypersensitivity to any component of the IMPs.
- •20.Contraindications to denosumab therapy(e.g.,hypocalcaemia),or calcium or vitamin D supplementation before starting the IMP administration.
- •21.Known allergic reactions,hypersensitivity,or intolerance to denosumab or to any ingredients of the IMP,including latex allergy.
- •22.Patient with seropositivity for human immunodeficiency virus infections at the time of screening.
- •23.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.
- •24.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.
- •25.Patients with confirmed COVID-19 infection within a month prior to screening.
结局指标
主要结局
Percent change from baseline in Bone Mineral Density (BMD) at the lumbar spine
时间窗: Month 12
Note: L1-L4 region should be included.
次要结局
- Percent change from baseline in BMD at the total hip and femoral neck(Month 6 and Month 12)
- Percent change from baseline in BMD at the lumbar spine(Month 6)
- Descriptive (pharmacokinetic [PK]) assessment of Serum denosumab concentration
- Number of patients with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
- Proportion of patients with treatment emergent anti-denosumab antibodies (binding and neutralizing)(month 3, 6, 9, and 12)
研究者
相似试验
尚未招募
4 期
Assessment of the protection offered by single dose of COVID-19 vaccines in individuals previously affected with COVID-19CTRI/2021/10/037099Indian Council of Medical research ICMR
已完成
3 期
Sub lingual immunotherapy of Nasal allergiesPerennial allergic rhinitis.Other allergic rhinitisIRCT2017042323235N9Vice chancellor for research, Mashhad University of Medical Sciences40
已完成
4 期
Protection and Safety of rabies vaccine when administered intradermallyCTRI/2012/06/002720I70
已完成
3 期
Safety and immunogenicity of rabies vaccines in animal bite cases administered using new one week intradermal regimeCTRI/2012/12/003230Department of Community Medicine Kempegowda Institute of Medical Sciences KIMS80
Unknown
3 期
A clinical trial to study immunogenicity and safety of Purified Chick Embryo Cell Culture Rabies Vaccine administered intradermallyCTRI/2010/091/000509Cadila Healthcare Ltd36