An Italian Observational Study to Evaluate Fracture Outcomes, Compliance to Treatment, Back Pain, Health-related Quality of Life in Patients With Severe Osteoporosis Treated According to Common Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 794
- 试验地点
- 1
- 主要终点
- Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication.
研究概览
简要总结
This observational study will evaluate the incidence of new vertebral and non vertebral fragility fractures in patients with severe osteoporosis treated with anabolic drugs. This study will also evaluate BMD, compliance to treatment, back pain and the health-related quality of life.
详细描述
The participants should be treated with anabolic therapy for osteoporosis (Teriparatide or PTH 1-84) for 18 months and should be followed up for subsequent 6 months. The treatment is expected to improve bone mineral density, back pain and reduce the risk of new fractures due to osteoporosis. The outcomes will be evaluated by bone densitometry at the lumbar spine and femoral neck, by standard radiographs, by measurements of bone formation marker (P1NP) and by questionnaires on back pain and quality of life. Postmenopausal women and men over 21 years old may be included if they have:
- at least 3 severe vertebral fractures
- 2 severe vertebral fractures and 1 hip fracture
- an incidental vertebral fracture or an hip fracture during treatment with antiresorptives prescribed for at least 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women and men older than 21 years affected by severe osteoporosis with an incidental vertebral or hip fracture during treatment with an antiresorptive, or having 3 or more severe vertebral fractures or having 2 severe vertebral fractures and an historical hip fracture.
排除标准
- •Any contraindication for the use of antiosteoporotic drug
- •Premenopausal women or men younger than 21 years
研究组 & 干预措施
Patients with severe osteoporosis
Postmenopausal women and men aged > 21 years old affected by severe osteoporosis
干预措施: Teriparatide (Drug)
结局指标
主要结局
Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication.
时间窗: From 0 to 24 months
次要结局
- Treatment compliance(From 0 to 24 months)
- Reason of discontinuation(From 0 to 24 months)
- BMD changes (lumbar and femoral BMD)(From 0 to 24 months)
- Changes in bone turnover marker measured by P1NP(From 0 to 24 months)
- Quality of Life (measured by EQ-5D of EuroQol Group)(From 0 to 24 months)
- Back Pain measured by visual analogue scale and back pain questionnaire(From 0 to 24 months)
- Assessment of motor performance and chair rising test(From 0 to 24 months)