CTRI/2023/03/050576招募中4 期
An Open-label, Single-arm, Multicenter Phase 4 Study to Evaluate Safety and Tolerability of Romosozumab (EVENITY®) in Postmenopausal Women in India with Osteoporosis and a High Risk of Fracture
Amgen Technology Pvt. Ltd.0 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
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Inclusion Criteria
- •101 Subject has provided informed consent prior to initiation of any study specific activities/procedures. OR Subject’s legally authorized representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the
- •ability of the subject to give written informed consent.
- •102 Postmenopausal women with osteoporosis at high risk of fracture at screening that are eligible to receive romosozumab (in accordance with the approved use) in the post-marketing setting in India.
- •Postmenopause is defined as no vaginal bleeding or spotting for 12 consecutive months prior to screening.
- •High risk of fracture defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
- •103 Subjects must have at least two vertebrae in the L1 through L4 region and at least one hip are evaluable by DXA, as assessed by the principal investigator, eg, based on lateral spine x-rays.
排除标准
- •Exclusion Criteria
- •201 Subject had previously taken or is currently taking romosozumab or a sclerostin antibody.
- •202 Subject had myocardial infarction or stroke within a year prior to entering this study.
- •203 Subject has hypocalcemia during screening as assessed by the central laboratory. Pre-existing hypocalcemia must be corrected prior to initiating therapy with romosozumab.
- •204 A history of systemic hypersensitivity to romosozumab or to any component of the product formulation.
- •205 Use of the following agents affecting bone metabolism
- •Strontium ranelate, or fluoride (for osteoporosis):
- •- more than 1 month of cumulative use within 5 years prior to enrollment.
- •Intravenous (IV) bisphosphonates.
- •IV Zoledronic acid:
- •- any dose received within 3 years prior to enrollment.
- •- more than 1 dose received within 5 years prior to enrollment.
- •IV ibandronate or IV pamidronate:
- •- any dose received within 12 months prior to enrollment.
- •- more than 3 years of cumulative use, unless last dose received = 5 years prior to enrollment.
- •Oral bisphosphonates:
- •- any dose received within 3 months prior to enrollment.
- •- more than 1 month of cumulative use between 3 and 12 months prior to enrollment.
- •- more than 3 years of cumulative use, unless last dose received = 5 years prior to enrollment.
- •Denosumab or any cathepsin K inhibitor, such as odanacatib (MK-0822):
- •- any dose received within 18 months prior to enrollment.
- •Teriparatide or any PTH analogs:
- •- any dose received within 3 months prior to enrollment.
- •- more than 1 month of cumulative use between 3 and 12 months prior to enrollment.
- •Systemic oral or transdermal estrogen or SERMs:
- •- more than 1 month of cumulative use within 6 months prior to enrollment.
- •Hormonal ablation therapy:
- •- more than 1 month of cumulative use within 6 months prior to enrollment.
- •Tibolone, cinacalcet, or calcitonin:
- •- any dose received within 3 months prior to enrollment.
- •Systemic glucocorticosteroids:
- •- = 5 mg prednisone equivalent per day for more than 14 days within 3 months prior to enrollment.
- •206 25 (OH) vitamin D levels < 20 ng/mL, as assessed by the central laboratory. Vitamin D repletion will be permitted, and subjects may be rescreened twice.
- •207 Subject has any medical condition or illness (acute, chronic, or a history of), which in the opinion of the Investigator might interfere with the evaluation of the
- •safety of the study product or may otherwise compromise the safety of the subject.
研究者
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