NCT00727493Unknown4 期
Evaluation of the Influence of Alendronate on Wound Healing After Dental Implants in Patients With Osteoporosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Dental CT
研究概览
简要总结
The purpose of this study is to evaluate the influence of alendronate therapy on the wound healing after dental implants in patients with osteoporosis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women > 2 years after menopause
- •Age between 60 and 75 years
- •Possibility to insert a dental implant
- •Osteoporosis as defined by WHO criteria (intervention group), or women without osteoporosis / osteopenia (non-intervention group)
排除标准
- •Pathological findings in the jaw bone
- •Chronic inflammatory rheumatoid disease
- •Bisphosphonate treatments during the last 12 months
- •Inflammatory or metabolic bone disease, excluding osteoporosis
- •Systemic corticosteroid treatments of more than one month within previous 12 months
- •Severe diseases with life expectancy less than one year or expectation of rapid worsening within one year
研究组 & 干预措施
1
Active Comparator
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant
干预措施: alendronate once weekly 70mg (Drug)
2
Placebo Comparator
placebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant
干预措施: placebo (Drug)
结局指标
主要结局
Dental CT
时间窗: baseline, and 3,6,12 months after baseline
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS)OsteoporosisAnkylosing SpondylitisNCT01104987Göteborg University16
已完成
4 期
Sodium Alendronate in Non Surgical Periodontal TherapyBone ResorptionPeriodontitisNCT02470611Federal University of Minas Gerais32
Unknown
1 期
Efficacy of Antiresorptive and Bone Forming Material on Dental ImplantsPartial EdentulismNCT04140006University of Baghdad20
Unknown
不适用
The Effectiveness of Two Osteoporosis Drugs on Prosthetic Bone Mineral Density (BMD) Loss After Total Hip Arthroplasty(THA)Bone DensityArthroplasty, Replacement, HipNCT01020253Yokohama City University Medical Center60
已完成
不适用
Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form)osteogenesis imperfectaJPRN-UMIN000010615Tohoku University School of Medicine, Department of Pediatrics10