EUCTR2007-002693-66-ES进行中（未招募）1 期
Ensayo clínico aleatorizado, controlado con placebo, en fase III, para evaluar la seguridad y la eficacia de odanacatib (MK-0822) en cuanto a la reducción del riesgo de fractura en mujeres posmenopáusicas con osteoporosis tratadas con vitamina D y calcio.A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of MK-0822 to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16,300
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
- •1.Patient is a woman and is >= 65 years of age on the day of signing informed consent.
- •2.Patient meets one of the following:
- •a)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-1.5 at either the total hip or femoral neck site, BMD T-score >=-4.0 at both sites, and has one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR-
- •b)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-2.5 at either the total hip or femoral neck site, BMD T-score >=-4.0 at both sites, and does not have a prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR -
- •c)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-1.5 at either the total hip or femoral neck site, and has at least one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR-
- •d)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), and has a BMD T-score <=-2.5 at either the total hip or femoral neck site.
- •3.The patient has at least one hip that is evaluable by DXA (e.g., contains no hardware from orthopedic procedures).
- •4.Patient has been postmenopausal for at least 5 years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
- •1.Patient is a woman and is >= 65 years of age on the day of signing informed consent.
- •2.Patient meets one of the following:
- •a)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-1.5 at either the total hip or femoral neck site, BMD T-score >=-4.0 at both sites, and has one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR-
- •b)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-2.5 at either the total hip or femoral neck site, BMD T-score >=-4.0 at both sites, and does not have a prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR -
- •c)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-1.5 at either the total hip or femoral neck site, and has at least one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR-
- •d)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), and has a BMD T-score <=-2.5 at either the total hip or femoral neck site.
- •3.The patient has at least one hip that is evaluable by DXA (e.g., contains no hardware from orthopedic procedures).
- •4.Patient has been postmenopausal for at least 5 years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
- •1.Patient is a woman and is >= 65 years of age on the day of signing informed consent.
- •2.Patient meets one of the following:
- •a)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-1.5 at either the total hip or femoral neck site, BMD T-score >=-4.0 at both sites, and has one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR-
- •b)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-2.5 at either the total hip or femoral neck site, BMD T-score >=-4.0 at both sites, and does not have a prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR -
- •c)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-1.5 at either the total hip or femoral neck site, and has at least one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR-
- •d)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), and has a BMD T-score <=-2.5 at either the total hip or femoral neck site.
- •3.The patient has at least one hip that is evaluable by DXA (e.g., contains no hardware from orthopedic procedures).
- •4.Patient has been postmenopausal for at least 5 years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Patient has chosen treatment with oral bisphosphonates or other agents demonstrated to reduce the risk of hip fracture.
- •2)Patient has had a prior hip fracture.
- •3)Patient experienced a clinical fragility fracture (including a clinical vertebral fracture) within 24 months. (Note: Finger, toe, and skull fractures should not be considered with regard to this exclusion criterion.)
- •4)Patient has had more than 1 prior vertebral fracture, as defined in Inclusion Criterion 1 above, and she is a suitable candidate for osteoporosis therapy (i.e., bisphosphonates, strontium, or PTH).
- •5)Patient has or has had evidence of a metabolic bone disorder other than osteoporosis.
- •1)Patient has chosen treatment with oral bisphosphonates or other agents demonstrated to reduce the risk of hip fracture.
- •2)Patient has had a prior hip fracture.
- •3)Patient experienced a clinical fragility fracture (including a clinical vertebral fracture) within 24 months. (Note: Finger, toe, and skull fractures should not be considered with regard to this exclusion criterion.)
- •4)Patient has had more than 1 prior vertebral fracture, as defined in Inclusion Criterion 1 above, and she is a suitable candidate for osteoporosis therapy (i.e., bisphosphonates, strontium, or PTH).
- •5)Patient has or has had evidence of a metabolic bone disorder other than osteoporosis.
- •1)Patient has chosen treatment with oral bisphosphonates or other agents demonstrated to reduce the risk of hip fracture.
- •2)Patient has had a prior hip fracture.
- •3)Patient experienced a clinical fragility fracture (including a clinical vertebral fracture) within 24 months. (Note: Finger, toe, and skull fractures should not be considered with regard to this exclusion criterion.)
- •4)Patient has had more than 1 prior vertebral fracture, as defined in Inclusion Criterion 1 above, and she is a suitable candidate for osteoporosis therapy (i.e., bisphosphonates, strontium, or PTH).
- •5)Patient has or has had evidence of a metabolic bone disorder other than osteoporosis.
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