A Randomized, Open-Label, Placebo-Controlled, Two-Period Crossover Study of the Effect on CTx-1 Concentrations of a Single 200 μg Recombinant Salmon Calcitonin (rsCT) Dose Given at Night to Normal, Healthy, Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacodynamic Effect of Oral Calcitonin
研究概览
简要总结
This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at night and to compare these results with those obtained with a placebo control and with commercially available nasal calcitonin.
详细描述
Timing of the dose of recombinant salmon calcitonin (rsCT) is important in effecting reduction of osteoclast activity. It is theorized that a dose administered before bedtime will be more effective than a dose administered in the morning. See protocol summary for information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History of parathyroid, thyroid, pituitary or adrenal diseases.
- •History of musculoskeletal disease.
- •History of gastro-esophageal reflux disease (GERD) or other significant gastrointestinal disorders.
- •History of cancer within 5 years of enrollment other than basal cell carcinoma.
- •History of regular use of a Non-Steroidal Anti-inflammatory Drug (NSAID).
- •History of surgery within 60 days of enrollment.
- •History of hypersensitivity or allergies (other than seasonal allergies) within -years of enrollment including known sensitivity to the active ingredients or the excipients in the study medications.
- •Use of concomitant medications other than acetaminophen within 7 days of enrollment or anticipated need to use such concomitant medications during the study.
- •Use of bisphosphonates within 6 months, SERMS, estrogen or estrogen-like drugs 2 months, or calcitonin 1 month.
- •Presence of any clinically significant illness.
- •Unwilling or unable to comply with all study requirements.
- •Unwilling or unable to sign written, informed consent.
- •History of drug or alcohol abuse.
- •Participation in any clinical study of an investigational drug within 60 days of enrollment.
- •Plasma CTx-1 less than 0.25 ng/mL.
研究组 & 干预措施
Part 1 Double Blind Oral rsCT Tablet
Intervention: Oral rsCT tablet given once 4 hours after evening meal.
干预措施: Oral rsCT tablet (Drug)
Part 1, Double-blind Oral Placebo Tablet
Intervention: Oral placebo tablet matching the oral rsCT tablet, given once 4 hours after evening meal
干预措施: Oral Placebo Tablet (Drug)
Part 2 Open label, Oral rsCT tablet
Intervention: Oral rsCT tablet given once 2 hours after evening meal.
干预措施: Oral rsCT tablet (Drug)
Part 2, Open Label Fortical Nasal Spray
Intervention: Part 2 Open label. Fortical (rsCT) nasal spray given once 2 hours after evening meal
干预措施: Fortical (rsCT) nasal spray (Drug)
结局指标
主要结局
Pharmacodynamic Effect of Oral Calcitonin
时间窗: 12 hr
C-terminal telopeptide of Collagen Type I (CTx-1) is an established plasma biomarker employed as an index of bone-resorption activity in response to interventions such as an anti-resorptive agent such as calcitonin. Here the calcitonin-salmon is rsCT, (recombinant) both oral and intranasal. These CTx-1 plasma concentrations were collected over 12 hours post-dosing where each subject served as her own control, as all received placebo in this crossover study, to account for the known diurnal variation of plasma CTx-1. For each time point, the ratio of the calcitonin response over the placebo response for that subject was derived from the plasma levels of CTx-1 and reported as a % of the placebo response (% Placebo or %P). These values were used to determine the primary pharmacodynamic parameter of Rmin, the minimum value seen following each active dose. The same %P values were used to derive the secondary pharmacodynamic parameters described in Secondary outc
次要结局
- Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women(12 hours)
- AUCInhibition=Hours*%P(12 Hours)