EUCTR2012-001921-29-DK进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of BA058 Presented as a Coated Transdermal Microarray Delivery System (BA058 Transdermal) in Healthy Postmenopausal Women with Osteoporosis - Not Applicable
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •The subject is a healthy ambulatory postmenopausal woman not older than 85 years of age with osteoporosis.
- •Subject has been postmenopausal for at least 5 years.
- •Subject has a BMD T-score = -2.5 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA).
- •- Subjects may also be included if they have a BMD T-score of = 2.0 and a prior low-trauma forearm, humerus, vertebral, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years
- •- or who have an additional risk factor such as age 65 to 85 , or a strong maternal history of osteoporosis.
- •Is in good general health as determined by medical history and physical examination (including vital signs)
- •The subject has serum calcium (albumin-corrected), PTH (1-84), serum phosphorus and alkaline phosphatase values all within the normal range during the Screening Period.
- •Has a serum 25-hydroxy vitamin D value >15 ng/mL (37.4 nmol/L) and within 3 times the upper normal range.
- •Subject’s resting 12-lead electrocardiogram shows no clinically significant abnormality and a QTc =470°msec (Bazett’s correction).
- •Subject’s systolic blood pressure is =100 and =155 mmHg, diastolic blood pressure is =40 and =95 mmHg, and heart rate is =45 and =100 bpm (sitting or supine).
- •Subject has no clinically significant abnormality of serum hemoglobin, hematocrit, WBC and platelets, or serum biochemistry: electrolytes, renal function, liver function and serum proteins.
- •Subject has signed the written informed consent form.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Abnormalities of the lumbar spine that would prohibit assessment of spinal BMD.
- •Unevaluable hip BMD or have undergone bilateral hip replacement
- •History of bone disorders (e.g., Paget’s disease).
- •Chronic radiation therapy other than radioiodine.
- •History of chronic or recurrent disease or medical condition that would interfere with the interpretation of study data or compromise the safety of the subject.
- •Significantly impaired renal function (serum creatinine >177 µmol/L or >2.0 mg/dL).
- •History of any cancer within the past 5 years.
- •History of osteosarcoma.
- •History of nephrolithiasis or urolithiasis within the past 5 years.
- •Decrease of 20 mmHg or more in systolic blood pressure or 10 mmHg or more in diastolic blood pressure from supine to standing and/or any symptomatic hypotension at screening
- •Positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-2.
- •Known hypersensitivity to any of the test materials or related compounds.
- •Prior treatment with PTH or PTHrP drugs.
- •Prior treatment with bisphosphonates or strontium in the past five years, or prior treatment with gallium nitrate, or with a bone-acting investigational agent at any time.
- •Prior treatment with denosumab, calcitonin, SERMs, tibolone, or anabolic steroids in the past 12 months.
- •Treatments with anticonvulsants that affect vitamin D metabolism or with heparin within the 6 months prior.
- •Daily treatment with oral, intranasal or inhaled corticosteroids above the equivalent of 5 mg oral cortisone per day within the 12 months prior.
- •Exposure to general anesthesia within the four weeks prior.
- •Exposure to an investigational drug within the 12 months prior.
- •Abnormal nutritional status, vitamin D intake of =4,000 IU/day or vitamin A intake of =10,000 IU/day.
- •Known to abuse alcohol or use illegal drugs within 12 months prior.
研究者
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