NCT00190944已完成2 期
Effects of Teriparatide on Distal Radius Fracture Healing
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 8
- 主要终点
- Time to radiographic healing
研究概览
简要总结
Effects of Teriparatide on Distal Radius Fracture Healing
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
- Double
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory, postmenopausal, women 45 to 85 years of age. Postmenopausal is defined as at least 2 years without regular menses
- •Sustained a unilateral, dorsally angulated fracture of the distal radius within 10 days
- •Received conservative treatment of her distal radius fracture, including closed reduction and immobilization device (such as cast, splint, or brace)
- •Free of severe or chronically disabling conditions other than a distal radius fracture as determined by the investigator
- •Without language barrier, cooperative, expected to return for all follow-up procedures, and has given informed consent before entering the study and after being informed of the risks, medications and procedures to be used in the study.
- •In the opinion of the investigator, the patient is willing to be trained and use the pen-injector daily, is able to satisfactorily use a pen-type injection delivery system, or is willing to receive daily subcutaneous injections from a care partner who has been trained to use the pen injector
排除标准
- •Increased baseline risk of osteosarcoma
- •History of a malignant neoplasm in the 5 years prior to visit 2, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated
- •Have currently known, suspected, or history of other diseases that affect bone metabolism other than postmenopausal osteoporosis or cause secondary osteoporosis that has been clinically active in the 1 year prior to visit 2
- •Have elevated serum calcium values
- •Active liver disease or clinical jaundice
- •History of symptomatic nephro-or urolithiasis in the 2 years prior to visit 2
- •Previous fractures or bone surgery in the currently fractured distal forearm
- •Joint disease such as rheumatoid arthritis or disabling osteoarthritis that clearly affect the function of the wrist and/or hand of the injured arm
- •Requirement for chronic treatment with nonsteroidal anti-inflammatory drugs defined as more than 3 consecutive months of any NSAID treatment
- •Treatment with:
- •Oral bisphosphonates for more than 18 months during the prior 3 years, or have received any oral or intravenous biphosphonate therapy within the last 2 months prior to screening.
- •Oral strontium ranelate for any duration
- •Systemic corticosteroids for more than 30 days (total) in the 6 months prior to visit 2, or any systemic corticosteroid dose in the 1 month prior to visit
- •Ophthalmic, oric, topical, or nasally inhaled corticosteroid therapy may be used without these restrictions.
- •Fluoride at therapeutic doses (greater than or equal to 20mg/day) for more than 3 months during the last 2 years or for more than a total of 2 years, or any dosages within the 6 months prior to visit 2.
结局指标
主要结局
Time to radiographic healing
次要结局
- There are no secondary outcomes for this trial
研究者
研究点 (8)
Loading locations...
相似试验
尚未招募
不适用
Does anti osteoporotic drug teriparatide helps in healing of open tibia fracturesCTRI/2022/11/047097Ganga Medical Centre and Hospitals Pvt Ltd
进行中（未招募）
不适用
The Effect of Teriparatide on Distal Radius Fracture Healing - GHCFracture of distal radius (Colles’) fractureEUCTR2004-000894-67-SEEli Lilly and Company105
进行中（未招募）
不适用
The Effect of Teriparatide on Distal Radius Fracture Healing - GHCFracture of distal radius (Colles’) fractureEUCTR2004-000894-67-ESilly S.A105
终止
不适用
Use of Teriparatide to Accelerate Fracture HealingPelvic FractureNCT00594906University of Rochester10
Unknown
3 期
Study of Teriparatide in Stress Fracture HealingStress FractureParathyroid HormoneNCT04196855University of East Anglia136