A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Assess the Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change from baseline to month 9 in bone mineral density at the lumbar spine for the individual BPS804 groups and pooled placebo arms.
研究概览
简要总结
This study is designed to provide information on the safety, tolerability, pharmacokinetics (PK) and bone biomarker response following multiple BPS804 administration in multiple dosing regimens. This information will permit a comparison of the possible risks and benefits of different dosing regimens of the study drug to enable optimal doses and dose intervals to be tested in subsequent studies.
详细描述
This study was conducted and previously posted by Novartis. The record was transferred to Ultragenyx in February 2021.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women (natural or surgically induced menopause)
- •Low bone mineral density (BMD), as defined by a T score or equivalent BMD absolute value (g/cm2) for lumbar spine of between -2.0 and -3.5, inclusive
- •Body mass index (BMI) must be within the range of 18 to 35kg/m
- •Subjects must weigh between 45 and 120kg inclusive to participate.
- •25-(OH) vitamin D serum level of ≥ 15ng/ml
- •Serum calcium within normal limits
排除标准
- •Subjects with suspected neural foraminal stenosis (e.g., cervical, spinal, lumbar), or history of Bell's palsy, cranial nerve disorders, temporomandibular joint and muscle disorders.
- •Subjects who have an increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained and clinically significant elevations of alkaline phosphatase and/or subjects who have received radiation therapy involving the skeleton.
- •Subjects with any known bone diseases other than postmenopausal osteoporosis.
- •Subjects with a history of an osteoporotic fracture (e.g., vertebral fracture, fragility fracture of the wrist, radius, humerus, hip, or pelvis).
- •Subjects who are regularly using or have regularly used agents affecting bone metabolism:
- •Calcitonin, estrogen, SERMs (raloxifene, Tamoxifen, etc.), Tibolone progestin, or androgens within the last three (3) months prior to screening.
- •Any oral bisphosphonate, lithium chloride, fluoride or systemic glucocorticosteroids (p.o. or i.v.) where the total dose exceeds 750 mg of prednisone or equivalent within the last year prior to screening.
- •Any previous use of denusomab (ProliaTM), parathyroid hormone (ForteoTM), and/or PTH analogs, strontium ranelate, or parenteral formulations of bisphosphonates.
- •Current disease(s) known to influence calcium metabolism including hyperparathyroidism, hypoparathyroidism, hypocalcemia or hypercalcemia.
- •Any disease, abnormality or deformation of the spine (e.g., scoliosis, ankylosing spondylitis, osteophytes) or hip (e.g., joint prosthesis) which would preclude the proper acquisition of a lumbar spine DXA (L1-L4) or femur DXA, respectively.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
placebo dosing frequency 1
Subjects dosed with matching placebo to 20mg/Kg BPS804 monthly
干预措施: Placebo to 20mg/Kg BPS804 (Drug)
BPS804 dosing frequency 1
Subjects dosed 20mg/Kg BPS804 monthly
干预措施: BPS804 20mg/Kg (Drug)
BPS804 dosing frequency 2
Subjects dosed with 20mg/Kg BPS804 quarterly
干预措施: BPS804 20mg/Kg (Drug)
placebo dosing frequency 2
Subjects dosed with matching placebo to 20mg/Kg BPS804 every 3 months
干预措施: Placebo to 20mg/Kg BPS804 (Drug)
BPS804 dosing frequency 3
Subjects dosed with 20mg/Kg BPS804 weekly
干预措施: BPS804 20mg/Kg (Drug)
Placebo dosing frequency 3
Subjects dosed with matching placebo to 20mg/Kg BPS804 weekly
干预措施: Placebo to 20mg/Kg BPS804 (Drug)
结局指标
主要结局
Change from baseline to month 9 in bone mineral density at the lumbar spine for the individual BPS804 groups and pooled placebo arms.
时间窗: 9 months
The number (percent) of subjects experiencing adverse events or serious adverse events
时间窗: 9 months
次要结局
- Characterization of the PK profile of BPS804: time to reach the maximum Characterization of the PK profile of BPS804: maximum plasma concentration (Cmax)(260 days)
- Change from baseline during 9 months of serological bone biomarkers for the individual BPS804 groups and pooled placebo arms.(9 months)
- Characterization of the PK profile of BPS804: area under the plasma concentration-time curve (AUC)(260 days)
- Characterization of the PK profile: time to reach the maximum concentration (Tmax)(260 days)
- Characterization of the PK profile of BPS804: half-life (T1/2)(260 days)