CTRI/2023/09/057671进行中（未招募）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. - NI
upin Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Postmenopausal women with osteoporosis. A woman is
- •considered postmenopausal if she meets any of the following
- •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.)
- •2. Age = 55 and = 80 years at the time of informed consent.
- •3. 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).
- •4. At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA.
- •5. 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
- •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 > 3 years 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
- •7. 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.
- •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, gonadotropinreleasing
- •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. Abnormal serum calcium (re-test and rescreening is permitted):
- •current hypocalcemia ( < 8.4 mg/dL).
- •12. 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).
- •13. 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.
- •14. Current or prior use of romosozumab or antisclerostin antibody.
- •15. Current hypoparathyroidism or hyperparathyroidism other than
- •clinically not significant secondary hyperparathyroidism as judged
- •by the investigator.
- 另有 7 项未显示
研究者
相似试验
招募中
3 期
Evaluation of efficacy, safety and immunogenicity of Lupins Denosumab compared to Prolia in postmenopausal women with osteoporosis.OsteoporosisJPRN-jRCT2031230117Sakine Michitoshi400
进行中（未招募）
1 期
A multicenter, randomized, double blind, parallel group, vehicle controlled, study of the safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 8 weeks in pediatric subjects (2 to 12 years of age) with mild to moderate plaque psoriasisPsoriasisEUCTR2014-001744-38-BEGALDERMA R&D, LLC300
进行中（未招募）
不适用
A multicenter, randomized, double blind, parallel group, vehicle controlled, study of the safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 8 weeks in pediatric subjects (2 to 12 years of age) with mild to moderate plaque psoriasisPsoriasisEUCTR2014-001744-38-HUGALDERMA R&D, LLC300
进行中（未招募）
1 期
A multicenter, randomized, double blind, parallel group, vehicle controlled, study of the safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 8 weeks in pediatric subjects (2 to 12 years of age) with mild to moderate plaque psoriasisEUCTR2014-001744-38-ITGALDERMA RESEARCH & DEVELOPMENT, LLC300
进行中（未招募）
1 期
A multicenter, randomized, double blind, parallel group, vehicle controlled, study of the safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 8 weeks in pediatric subjects (2 to 12 years of age) with mild to moderate plaque psoriasisEUCTR2014-001744-38-DEGALDERMA R&D, LLC300