A Study to Assess the Effects on Serum Calcium When Teriparatide is Used With Active Vitamin D in Osteoporosis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)
研究概览
简要总结
The purpose of this trial is to assess the effects on serum calcium when teriparatide is used with active vitamin D in osteoporosis patients.
This study consists of a Screening Period, a 14-day Lead-in Period, a 28-day Treatment Period, and a 7-day Follow-up Period. Patients will take vitamin D and calcium supplementation from the Lead-in Period throughout the study. During the Treatment Period, daily administration of teriparatide will be added.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory Japanese males or postmenopausal females with osteoporosis, as determined by the Japanese Society for Bone and Mineral Research (JSBMR) diagnostic criteria
排除标准
- •Prior treatment with parathyroid hormone (PTH) or any PTH analog
- •History of metabolic bone disorders other than primary osteoporosis
- •Fractures caused by diseases other than osteoporosis
- •Abnormal thyroid function
- •Hyperparathyroidism or hypoparathyroidism
- •Severe or chronically disabling conditions other than osteoporosis
- •Currently has or has a history of spruce, inflammatory bowel disease, or malabsorption syndrome
- •Currently has, or a has a history of, nephrolithiasis or urolithiasis in the 2 years prior to screening
- •Clinically significant abnormal laboratory values or electrocardiogram
- •Treatment with oral bisphosphonates at any time in the 3 months prior to enrollment, treatment with any bisphosphonate for more than 60 days in the 6 months prior to enrollment, or with intravenous bisphosphonates at any time in the 24 months prior to enrollment; or in case of oral bisphosphonates administered once a week, the equivalent as the above
- •Treatment with injectable calcitonin in the 3 months prior to enrollment
- •Treatment with raloxifene hydrochloride for more than 3 months in the 6 months prior to enrollment
- •Treatment with systemic corticosteroids, except for orally inhaled or nasally inhaled corticosteroids, in doses <= 800 micrograms per day (µg/day) beclomethasone dipropionate or equivalent in the 3 months prior to screening, or for more than 30 days in the 12 months prior to enrollment
- •Treatment with anticonvulsants, except for benzodiazepines, in the 6 months prior to enrollment
- •Prior treatment with strontiumranate or denosumab (anti-RANKL antibody)
- •Prior external beam radiation therapy involving the skeleton
- •Current or a history of malignant neoplasm in the 5 years prior to screening, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that had been definitively treated
研究组 & 干预措施
Teriparatide + Aspara-CA + Alfarol
Aspara-CA 600 milligrams (mg) and Alfarol 1.0 microgram (µg) administered orally once daily throughout the study. Teriparatide 20 µg administered subcutaneously once daily for 28 days during the Treatment Period.
干预措施: Teriparatide (Drug)
Teriparatide + Aspara-CA + Alfarol
Aspara-CA 600 milligrams (mg) and Alfarol 1.0 microgram (µg) administered orally once daily throughout the study. Teriparatide 20 µg administered subcutaneously once daily for 28 days during the Treatment Period.
干预措施: Aspara-CA 600 mg (Drug)
Teriparatide + Aspara-CA + Alfarol
Aspara-CA 600 milligrams (mg) and Alfarol 1.0 microgram (µg) administered orally once daily throughout the study. Teriparatide 20 µg administered subcutaneously once daily for 28 days during the Treatment Period.
干预措施: Alfarol 1.0 µg (Drug)
结局指标
主要结局
Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)
时间窗: Day 28 (16 and 24 hours postdose)
Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). Postdose refers to after Teriparatide dose.
次要结局
- Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline(Day 1 up to Day 28 (Teriparatide Treatment Period))
- Mean Serum Calcium Levels(Baseline (Day -1 of 14-day Lead-in Period) and Day 1 and Day 7 and Day 14 and Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period))
- Change From Baseline in Serum Calcium(Baseline (Day -1 of the 14-day Lead-in Period), Day 1, Day 7, Day 14, Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period))
- Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline(Day 1 up to Day 28 (28-day Teriparatide Treatment Period))
- Mean Daily Urine Calcium Excreted(Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period))
- Change From Baseline in Daily Urine Calcium Excreted(Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period))
- Concentrations of Serum 25-Hydroxy-Vitamin D(Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period))
- Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3(Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period))