EUCTR2017-000675-90-LT进行中（未招募）1 期
A Phase 3b, Multicenter, Randomized, Double-blind, Parallel Group, Alendronate-Controlled Study in Postmenopausal Women with Osteoporosis Previously Treated with Romosozumab Followed by Alendronate Sequential Therapy
Amgen Inc.0 个研究点目标入组 150 人开始时间: 2017年4月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Subject has provided informed consent/assent prior to initiation of any study
- •specific activities/procedures.
- •Subject’s legally acceptable 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.
- •Females who were initially randomized to the romosozumab to ALN sequential
- •treatment arm of the ARCH study and
- •- who have completed the Month 36 visit of the ARCH study
- •- who did not discontinue investigational product during the ARCH study and therein received at least 75% of planned romosozumab and ALN dosing
- •Subject meets the following BMD criteria
- •- Subject has a DXA BMD T-score = -2.0 at the total hip or femoral neck (at or within 4 weeks of the start of screening), as assessed by imaging vendor.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Disease Related
- •Subjects with a positively adjudicated osteonecrosis of the jaw (ONJ) or atypical femoral fracture (AFF) event in the ARCH study or any history of ONJ or AFF events.
- •Vitamin D insufficiency (defined as 25 (OH) vitamin D levels < 20 ng/mL as determined by the central laboratory). Vitamin D repletion and retesting within the screening window will be permitted.
- •Current, uncontrolled hyper- or hypothyroidism. Uncontrolled hyperthyroidism is defined as thyroid-stimulating hormone (TSH) and thyroxine (T4) outside the normal range. Uncontrolled hypothyroidism is defined as TSH > 10.
- •Current, uncontrolled hyperparathyroidism or history of hypoparathyroidism, per subject report or chart review. Uncontrolled hyperparathyroidism is defined as:
- •PTH outside the normal range in subjects with concurrent hypercalcemia; or PTH values > 20% above the upper limit of normal (ULN) in normocalcemic subjects.
- •Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory.
- •Albumin-adjusted serum calcium levels may be retested once in case of an elevated albumin-adjusted serum calcium level within 1.1 x the ULN as assessed by the central laboratory.
- •History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as sclerosteosis, Paget’s disease.
- •Other Medical Conditions
- •Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years from the start of this study.
- •Possible diagnosis of multiple myeloma or related lymphoproliferative disorder, as assessed by serum protein electrophoresis performed by the local laboratory (electrophoresis results within 6 months of signing consent will be acceptable).
- •Positive for Hepatitis B.
- •Positive for Hepatitis C, Chronic Hepatitis C, and negative viral load while receiving treatment for Hepatitis C.
- •Positive results for Human Immunodeficiency Virus (HIV) or known to be HIV-positive
- •Prior/Concomitant Therapy
- •Subjects who have stopped taking ALN for > 3 months since ending the ARCH study and prior to enrollment in this study.
- •Use of strontium ranelate, or fluoride (for osteoporosis): more than 1 month of cumulative use within 5 years prior to randomization for, during, or after completion of the ARCH study.
- •Use of Intravenous (IV) bisphosphonates.
- •- Zoledronic acid:
- •o any dose received within 3 years prior to randomization for, during, or after completion of the ARCH study
- •o more than 1 dose received within 5 years prior to randomization for, during, or after completion of the ARCH study
- •- IV ibandronate or IV pamidronate:
- •o any dose received within 12 months prior to randomization for, during, or after completion of the ARCH study
- •o more than 3 years of cumulative use, unless last dose received = 5 years prior to randomization for the ARCH study
- •o Use of oral bisphosphonates:
- •- any dose received within 3 months prior to randomization for, during, or after completion of the ARCH study
- •- more than 1 month of cumulative use between 3 and 12 months prior to randomization for, during, or after completion of the ARCH study
- •- more than 3 years of cumulative use, unless last dose received = 5 years prior to randomization for the ARCH study
- •Use of denosumab or any cathepsin K inhibitor, such as odanacatib (MK-0822): any dose received within 18 mont
研究者
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