A Prospective Open-Label, Multicenter Study to Evaluate the Change in Bone Turnover Markers After Once Monthly Oral Ibandronate Therapy in Treatment Naive Postmenopausal Osteoporosis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 308
- 主要终点
- Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)
研究概览
简要总结
This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women newly diagnosed with postmenopausal osteoporosis
- •Naive to prior bisphosphonate therapy
排除标准
- •Inability to stand or sit upright for at least 60 minutes
- •Inability to swallow a tablet whole
- •Hypersensitivity to any component of ibandronate
- •Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
- •Other osteoporosis drug within last 3 months
- •Malignant disease diagnosed within previous 10 years, except resected basal cell cancer
研究组 & 干预措施
Ibandronate Group 1
Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results.
干预措施: Ibandronate (Drug)
Ibandronate Group 2
Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.
干预措施: Ibandronate (Drug)
结局指标
主要结局
Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)
时间窗: Baseline, Month 6
Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
次要结局
- Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)(Baseline, Month 6)
- Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)(Baseline, Month 6)
- Percent Change From Baseline to Month 6 in Serum Osteocalcin(Baseline, Month 6)
- Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)(Baseline, Month 6)
- Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6(Month 6)