CTRI/2011/12/002257已完成3 期
A Six-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Denosumab in Indian Postmenopausal Women with Osteoporosis..
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 12
- 主要终点
- To assess between the denosumab and placebo treatment groups:Percent change in BMD at the lumbar spine from Baseline to Month 6
研究概览
简要总结
The aim of this Phase III, randomized, double-blind, placebo-controlled,parallel-group, multicenter study is to evaluate the efficacy and safety of denosumab in Indian postmenopausal women with osteoporosis. The study design consists of two phases: Screening and 6-month Double-Blind treatment phase. Following theScreening phase, all eligible subjects will be randomized to receive double-blind Denosumab (60 mg) or Placebo (PBO) study medication in a 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 55.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subject is willing and able to provide written informed consent.
- •Of Indian origin – defined as a person having origins from the Indian subcontinent (India, Pakistan, Bangladesh and Sri Lanka).
- •Ambulatory woman between the age of 55and 75 years, inclusive.
- •The subject has a BMD absolute value consistent with a T-score < -2.5 and > -4.0 at either the lumbar spine or total hip.
- •[Table 2 provides BMD equivalents by T-score thresholds for each DXA scanner manufacturer.
- •The BMD equivalent for corresponding T-score must be < -2.5 and > -4.0 for a subject to be eligible].
- •Postmenopausal defined as >5-years postmenopausal, which can be >5-years of spontaneous amenorrhea or >5-years post surgical bilateral oophorectomy.
- •Use follicle stimulating hormone (FSH) levels > 40 mIU/mL to confirm surgical postmenopausal status, where bilateral oophorectomy status is uncertain.
排除标准
- •Previous or Current Medical Conditions:
- •Bone/metabolic disease: a.
- •Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings.
- •Paget’s disease c.
- •Cushing’s disease d.
- •Hyperprolactinemia
- •Current hyperparathyroidism or hypoparathyroidism
- •Thyroid condition: Hyper- or hypothyroidism; however, subjects on stable thyroid hormone replacement therapy may be allowed per the following criteria: a.
- •If TSH level is below normal range, subject is not eligible for the study.
- •If TSH level is elevated ( 5.5 μIU/mL to 10.0 μIU/mL), serum T4 should be measured.
- •â€¢ If serum T4 is within normal range, subject is eligible.
- •â€¢ If serum T4 is outside of normal range, subject is not eligible for the study.
- •Rheumatoid arthritis
- •Malignancy: a.
- •Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5-years.
- •Malabsorption syndrome: malabsorption syndrome or any gastrointestinal disorders associated with malabsorption.
- •Liver disease: a.
- •Cirrhosis of the liver b.
- •Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
- •Chronic stable hepatitis B and C are acceptable, if subject otherwise meet study entry criteria (e.g., presence of hepatitis B surface antigen or positive Hepatitis C test result within 3-months of Screening).
- •Drug or alcohol abuse: Evidence of alcohol or substance-abuse within the last 12-months which the Investigator believes would interfere with understanding or completing the study.
- •Biological abnormalities: a.
- •Any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures.
- •Any physical or psychiatric disorder which, in the opinion of the Investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results.
- •Known to have tested positive for human immunodeficiency virus (HIV).
- •Vitamin D deficiency: Vitamin D deficiency (25-(OH) vitamin D level 20 ng/mL).
- •Vitamin D repletion will be permitted and subjects may be re-tested with 25-(OH) vitamin D.
- •Oral/Dental Conditions a.
- •Active dental or jaw condition which requires oral surgery.
- •Planned invasive dental procedure.
- •Non-healed dental or oral surgery.
- •Concomitant Medications:
- •Previous strontium or IV bisphosphonate: Administration of intravenous (IV) bisphosphonate, fluoride, or strontium for osteoporosis within the last 5-years.
- •Oral bisphosphonate: Oral bisphosphonate treatment for osteoporosis: a.
- •If used for ≥3-years cumulatively, subject is ineligible.
- •If used for 3-months but 3-years cumulatively: • If the last dose was 1-year before enrolment, subject is ineligible.
- •If used ≤3-months, cumulatively, subject is eligible.
- •Bone metabolism drugs: Administration of any of the following treatments within the last 6-weeks: a.
- •Systemic hormone replacement therapy.
- •Selective estrogen receptor modulators (SERMs), e.g., raloxifene f.
- •Tibolone g.
- •Calcitonin h.
- •Calcitriol or vitamin D derivatives i.
- •Other bone active drugs including anti-convulsives (except benzodiazepines) and heparin.
- •Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists.
- •Investigational drug exposure: Currently enrolled in or has not yet completed at least 30-days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
- •Sensitivity: Known sensitivity to mammalian cell derived drug products.
- •Abnormal laboratory values
- •General: Any laboratory abnormality which, in the opinion of the Investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results.
- •Albuminadjusted serum calcium levels must be within normal limits of the central laboratory.
- 另有 7 项未显示
结局指标
主要结局
To assess between the denosumab and placebo treatment groups:Percent change in BMD at the lumbar spine from Baseline to Month 6
时间窗: To assess between the denosumab and placebo treatment groups:Percent change in BMD at the lumbar spine from Baseline to Month 6
次要结局
- To assess between the denosumab and placebo treatment groups:Percent change in BMD at the total hip from Baseline to Month 6.(6 month)
- To assess between the denosumab and placebo treatment groups:Percent change in BMD at the femoral neck and trochanter from Baseline to Month(6.)
- To assess between the denosumab and placebo treatment groupsPercent change in serum CTX and P1NP from Baseline to Months 1, 3 and 6.(Month 1,3 and 6)
研究者
研究点 (12)
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