Can Risedronate and Parathyroid Hormone Reverse Glucocorticoid Induced Osteoporosis?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months.
研究概览
简要总结
The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. During the second year, the study will also look at whether taking risedronate will preserve the bone thickness created by one year of rhPTH 1-34 treatment.
详细描述
Dr. Nancy Lane and colleagues at the University of California, Davis and University of California, San Francisco will be conducting this 2-year study of human parathyroid hormone (rhPTH 1-34) alone, and rhPTH (1-34) with risedronate compared to risedronate alone in men and women with osteopenia on chronic low dose glucocorticoids (GC). This is an investigator-initiated study funded by Aventis Pharmaceuticals.
The study will be divided into 2 phases. All study subjects will receive supplemental calcium citrate and Vitamin D during the 2-year study. In year one subjects will be randomly assigned to receive PTH (subcutaneously daily) or placebo and risedronate tablets or placebo. In year two, PTH will be stopped and subjects in group 1 will be re-randomized to receive risedronate tablets or placebo. Subjects in group 2 and 3 will continue on risedronate tablets.
In year one of the study, subjects were randomly assigned to one of the following treatment groups.
- Group 1: rhPTH (1-34) (20ug subcutaneously daily) + riesdronate placebo tablets
- Group 2: rhPTh (1-34) (20ug subcutaneously daily) + risedronate tablets (35mg/wk)
- Group 3: rhPTh placebo (subcutaneous injections of normal saline) + risedronate tablets (35mg/wk)
In year two of the study, beginning at the 12 month timepoint
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, greater than 18 years of age with a history of glucocorticoid therapy with prednisone ≥ 7.5mg/d for 6 months, and currently on prednisone ≥ 5mg /day.
- •DXA of the lumbar spine (L1-L4) or total hip or femoral neck T score ≤ -1.5 with or without a prevalent vertebral fracture. (The T score is the number of standard deviations above or below the population mean for young, normal pre-menopausal females age 30).
- •Investigators are satisfied that that there is no physical condition that would prevent a patient from receiving the proposed treatment regimens.
- •Patient is ambulatory and able to return to the site of the investigation at specified time during the study.
- •The patient is willing to participate in the proposed study as evidenced by signing an informed consent.
- •Women of childbearing age are willing to use 2 forms of contraception during the entire study period.
- •Have at least one analyzable BMD site: lumbar spine and/or proximal femur
排除标准
- •Generalized disease of bone other than related to a rheumatic disease and glucocorticoid-induced osteoporosis including: hyperparathyroidism, hypoparathyroidism, Paget's disease of bone
- •Diseases that may affect bone metabolism including: alcoholism, hyperthyroidism, renal impairment (creatinine > 2.5mg/dl) or hepatic impairment (SGOT levels > 2x upper limit of normal
- •Urinary excretion of calcium > 400mg/day
- •History of drug abuse
- •Previous use of alendronate within 6 months prior to the study
- •Previous use of risedronate, hormone replacement therapy or calcitonin within 2 months prior to the study
- •History of unstable cardiovascular disease or uncontrolled hypertension
- •Severe scoliosis, greater than 2 lumbar fractures, or spinal surgery such that a precise bone mass measurement could be affected
- •History of gastrointestinal intolerance to bisphosphonates
- •History of cancer within 5 years of the study
- •Patients on glucocorticoids for organ transplantation
研究组 & 干预措施
Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2)
First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - re-randomized to risedronate (35mg/wk) tablets for second year.
干预措施: Risedronate (Drug)
Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2)
First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - re-randomized to risedronate (35mg/wk) tablets for second year.
干预措施: Parathyroid Hormone (Drug)
Group1b-rhPTH&RisendronatePlacebo
First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - continue on risedronate placebo tablets for second year.
干预措施: Parathyroid Hormone (Drug)
Group2-rhPTH&Risedronate
First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.
干预措施: Risedronate (Drug)
Group2-rhPTH&Risedronate
First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.
干预措施: Parathyroid Hormone (Drug)
Group3-rhPTH-Placebo&Risedronate
First phase (year 1) - parathyroid hormone (rhPTH 1-34), placebo SC injections of normal saline daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.
干预措施: Risedronate (Drug)
结局指标
主要结局
Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months.
时间窗: BMD changes from year 1 to year 2
In this randomized clinical trial to determine if treatment with rhPTH (1-34) with and without risedronate will increase bone mass of the lumbar spine more than risedronate alone. This was a small pilot study and study subjects were recruited from two study sites. Our primary endpoint was change in lumbar spine BMD.
次要结局
未报告次要终点
研究者
Nancy E. Lane, MD
Principal Investigator
University of California, Davis