A Multicenter, Randomized, Cross-Over, Open-label Study to Evaluate the Adherence, Preference, and Satisfaction of Denosumab and Alendronate in Postmenopausal Women With Low Bone Mineral Density
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 250
- 主要终点
- Adherence With Treatment in the First Treatment Period
研究概览
简要总结
The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW) treatment at the end of treatment period 1 (12 months).
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
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory postmenopausal women based on medical history
- •> or = 55 years of age at the start of screening
- •Screening bone mineral density (BMD) values (g/cm²), at the lumbar spine OR femoral neck OR total hip that occur within the specified ranges based on the particular scanner that is used. At least 2 lumbar vertebrae must be evaluable by Dual X-ray Absorptiometry (DXA), or at least one hip must be evaluable by DXA
- •Provide written informed consent before any study specific procedure is performed.
排除标准
- •Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- •Hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on thyroid hormone replacement therapy are allowed
- •Current hyper- or hypoparathyroidism
- •Current hypo- or hyper calcemia based on the central laboratory reference ranges for albumin-adjusted serum calcium
- •Rheumatoid arthritis, Paget's disease, Cushing's disease, hyperprolactinemia, or cirrhosis of the liver
- •Any metabolic bone disease, e.g. osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
- •Any symptomatic vertebral fracture within 3 months prior to screening
- •Previous participation in clinical trials with denosumab
- •Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (<49.9 nmol/L)]
- •Contraindicated to alendronate therapy; contraindications for alendronate therapy include:
- •Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia.
- •Inability to stand or sit upright for at least 30 minutes.
- •Hypersensitivity to alendronate (ALN) or other constituents of ALN tablets.
- •Any known prior bisphosphonate use
- •Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trail (s), or subject is receiving other investigational agent(s).
研究组 & 干预措施
Treatment Sequence B
When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment Sequences. Subjects randomized to treatment sequence B will receive 70 mg oral alendronate QW for 1-year (Treatment period 1) followed by denosumab 60 mg Q6M SC for 1 year (Treatment Period 2).
干预措施: alendronate (Drug)
Treatment Sequence B
When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment Sequences. Subjects randomized to treatment sequence B will receive 70 mg oral alendronate QW for 1-year (Treatment period 1) followed by denosumab 60 mg Q6M SC for 1 year (Treatment Period 2).
干预措施: denosumab (Drug)
Treatment Sequence A
When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment sequences. Subjects randomized to treatment sequence A will receive 60 mg denosumab Q6M SC for 1-year (Treatment period 1) followed by oral alendronate 70 mg QW for 1 year (Treatment period 2).
干预措施: alendronate (Drug)
Treatment Sequence A
When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment sequences. Subjects randomized to treatment sequence A will receive 60 mg denosumab Q6M SC for 1-year (Treatment period 1) followed by oral alendronate 70 mg QW for 1 year (Treatment period 2).
干预措施: denosumab (Drug)
结局指标
主要结局
Adherence With Treatment in the First Treatment Period
时间窗: Treatment period 1 (Month 1 to Month 12)
A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed non-adherent to treatment.
次要结局
- Compliance With Treatment in the Second Treatment Period(Treatment period 2 (Month 13 to Month 24))
- Time to Non-compliance to Alendronate Treatment in the Second Treatment Period(Treatment period 2 (Month 13 to Month 24))
- Time to Non-persistence to Alendronate Treatment in the First Treatment Period(Treatment period 1 (Month 1 to Month 12))
- Time to Non-compliance to Alendronate Treatment in the First Treatment Period(Treatment period 1 (Month 1 to Month 12))
- Beliefs About Medicines Questionnaire (BMQ) Preference Score(Baseline and Month 6, Month 12, Month 18, and Month 24)
- Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period(Month 6, Month 12 (treatment period 1))
- Compliance With Treatment in the First Treatment Period(Treatment period 1 (Month 1 to Month 12))
- Time to Non-persistence to Alendronate Treatment in the Second Treatment Period(Treatment period 2 (Month 13 to Month 24))
- Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period(Month 18, Month 24 (treatment period 2))
- Adherence With Treatment in the Second Treatment Period(Treatment period 2 (Months 13 to 24))
- Time to Non-adherence to Alendronate Treatment in the First Treatment Period(Treatment Period 1 (Month 1 to Month 12))
- Persistence With Treatment in the First Treatment Period(Treatment period 1 (Month 1 to Month 12))
- Persistence With Treatment in the Second Treatment Period(Treatment period 2 (Month 13 to Month 24))
- Time to Non-adherence to Alendronate Treatment in the Second Treatment Period(Treatment Period 2 (Month 13 to Month 24))
- Overall Satisfaction to Study Treatment(End of treatment period 1 (Month 12))
- Beliefs About Medicines Questionnaire (BMQ): Necessity Score(Baseline, Month 6, Month 12, Month 18 and Month 24)
- Beliefs About Medicines Questionnaire (BMQ) Concern Score(Baseline and Month 6, Month 12, Month 18, and Month 24)