Bone Sparing by Calcium Salts With and Without Extra Phosphorus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter.
研究概览
简要总结
Osteoporosis causes bones to weaken and break more easily. Calcium and phosphorus are two minerals that are essential for normal bone formation. Unfortunately, calcium salts commonly prescribed in anti-osteoporosis treatment bind phosphorus from food and restrict phosphorus available for bone building. Teriparatide is a drug that reduces the risk of fractures by increasing bone thickness and strength. Vitamin D is also necessary for strong bones and teeth. The purpose of this study is to evaluate the bone-building effectiveness of two calcium supplements, one with a source of phosphorus and one without, in combination with teriparatide and vitamin D in women with osteoporosis.
详细描述
Osteoporosis is the most common type of bone disease. Calcium supplements normally used in anti-osteoporosis treatment are calcium salts of carbonate or citrate; however, these salts bind phosphorus from food in the intestine and restrict phosphorus available for bone building. This study will evaluate the efficacy of adding calcium phosphate to a regimen of teriparatide and vitamin D in increasing bone mineral density in women with osteoporosis. It is hypothesized that the group taking the phosphate-containing calcium supplement will have greater gains in bone mineral density (BMD) during the course of the study than the group not receiving phosphate.
All participants will receive teriparatide and vitamin D during the course of the 12-month study. Participants will be randomly assigned to one of two groups. One group will receive calcium phosphate and the other will receive calcium carbonate. BMD will be measured at spine and hip at baseline and at 3, 6, and 12 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Bone mineral density (BMD) T-score less than -1.0
- •One or more vertebral fractures
- •Serum creatinine less than 1.3 mg/dL
- •Serum phosphorus less than 3.6 mg/dL
- •Daily phosphorus intake below NHANES-III median
- •Body mass index (BMI) less than 30 kg/m2
排除标准
- •Paget's disease or history of osteosarcoma
- •Systemic corticosteroid therapy
- •Hyperparathyroidism
- •Recent history of kidney stone
- •Anticonvulsant therapy known to alter vitamin D metabolism
- •Radiation therapy to bone
研究组 & 干预措施
Calcium Phosphate Treatment Group
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
干预措施: Calcium Phosphate (Drug)
Calcium Carbonate Treatment Group
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
干预措施: Calcium carbonate (Drug)
结局指标
主要结局
Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter.
时间窗: Measured at Baseline
Bone mineral density (BMD, measured by dual X-ray absorptiometry - DEXA) measured at several intervals during the study. BMD measured as grams per square centimeter (g/cm2).
Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide).
时间窗: 12 months
The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide).
次要结局
- Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months(Measured at baseline and 12 months)
- Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months(Measured at baseline and 12 months)
- Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months(Measured at baseline and 12 months)
- Change From Baseline in Urinary N-telopeptide at 12 Months(Measured at baseline and 12 months)