Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.
研究概览
简要总结
The study hypothesis is that nutritional supplementation together with bisphosphonates have a better preserving effect on bone mineral density (BMD) after hip fracture than bisphosphonates alone and that nutritional supplementation given postoperatively for 6 months preserve lean body mass in elderly hip fracture patients.
详细描述
Inclusion criteria: Men and women, ≥ 60 years of age with a recent fracture of the femoral neck or trochanter, admitted to any of the four University hospitals in Stockholm, Sweden. Patients are randomized into three groups by sealed enveloped technique in blocks by 12, thus assuring that each center had an equal distribution of patients in the three treatment groups. Patients randomly assigned and followed for 12 months. Each center with a doctor in charge and a trial nurse. The trial nurse in collaboration with the doctor are responsible of the randomization procedure and that blood samples are taken in the morning of the first weekday after inclusion at the ward and further that the dual-energy X-ray (DXA) and all estimates are done during hospital stay.The pharmacological treatment and nutritional supplementation starts as soon as the patients are circulatory stable, able to take food by mouth and are able to sit in an upright position one hour after taking the tablets.Patients are examined at baseline with a follow up at 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Recent fracture of the femoral neck or trochanter
- •Without severe cognitive impairment
- •Ambulant before fracture
排除标准
- •Abnormal parameters regarding liver i.e. S-Alanine aminotransferase (S-ALAT) and S-Aspartate aminotransferase (S-ASAT) ≥ twice as normal
- •Abnormal parameters regarding kidney i.e. S-Creatinine > 130 µg/L
- •Primary hyperparathyroidism, osteogenesis imperfecta, Paget´s disease
- •Lactose intolerance
- •Dysphagia
- •Esophagitis
- •Gastric ulcer
- •Malignancy
- •Diabetes with nephropathy or retinopathy
- •Active iritis or uveitis
研究组 & 干预措施
Risedronate
35 mg risedronate orally administered once weekly for 12 months and orally administered Calcium 1000 mg and 800 IU vitamin D3 daily for 12 months. Group B (bisphosphonate group)
干预措施: Risedronate (Drug)
Risedronate
35 mg risedronate orally administered once weekly for 12 months and orally administered Calcium 1000 mg and 800 IU vitamin D3 daily for 12 months. Group B (bisphosphonate group)
干预措施: Calcium and vitamin D3 (Dietary Supplement)
Nutritional supplement
Oral liquid nutritional supplement (600kcal and 40 gram protein/day) for 6 months after the hip fracture besides Risedronate and calcium and vitamin D3. Group BN (bisphosphonate and nutritional supplemented group)
干预措施: Risedronate (Drug)
Nutritional supplement
Oral liquid nutritional supplement (600kcal and 40 gram protein/day) for 6 months after the hip fracture besides Risedronate and calcium and vitamin D3. Group BN (bisphosphonate and nutritional supplemented group)
干预措施: Nutritional supplement (Other)
Nutritional supplement
Oral liquid nutritional supplement (600kcal and 40 gram protein/day) for 6 months after the hip fracture besides Risedronate and calcium and vitamin D3. Group BN (bisphosphonate and nutritional supplemented group)
干预措施: Calcium and vitamin D3 (Dietary Supplement)
Calcium and vitamin D3
An oral dose of 1000 mg Calcium and 800 IU vitamin D3 daily for 12 months after hip fracture. Group C (control)
干预措施: Calcium and vitamin D3 (Dietary Supplement)
结局指标
主要结局
Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.
时间窗: Baseline, 6 months and 12 months
Total body mineral density (BMD) were assessed by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm\^2). The change in BMD between baseline, 6 and 12 months was registered.
Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.
时间窗: Baseline, 6 months and 12 months
Total hip bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm\^2). The change in BMD between baseline, 6 and 12 months was registered.
次要结局
- Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture.(Baseline, 6 and 12 months)
- Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture.(Baseline, 6 and 12 months)