Jeffcoat Marjorie K
University of Pennsylvania School of Dental Medicine, Philadelphia, Pennsylvania 19104, USA.
Int J Oral Maxillofac Implants. 2006 May-Jun;21(3):349-53.
Osteoporosis and osteopenia are characterized by reductions in bone mass and may lead to skeletal fragility and fracture. The latest generation of oral bisphosphonate drugs, including alendronate and risendronate, has been approved for the prevention and treatment of osteoporosis. These medications are chemically absorbed into bone, decreasing osteoclast number and activity and thereby decreasing bone resorption. The purpose of this report is to present safety data from 2 controlled studies in patients receiving oral bisphosphonates.
Study 1 tested the effect of alendronate, an inhibitor of bone resorption, on alveolar bone. A total of 335 patients (162 men and 173 women, aged 30 to 79 years) with moderate or severe periodontal disease were randomized to either placebo or 70 mg alendronate once weekly. Alveolar bone height and safety were assessed over a 2-year period. Study 2 was a longitudinal single-blind controlled design comparing implant success in 50 consecutive patients (210 implants), 25 patients who received bisphosphonate therapy and 25 age-matched control subjects. Implant success and safety, including incidence of osteonecrosis of the jaws (ONJ), was blindly assessed for at least 3 years.
In study 1, no cases of ONJ were observed in either treatment group. Furthermore, a trend toward lower incidences of infection and tooth loss was observed in the alendronate group. In study 2, no cases of ONJ were observed in either group, and implant success was greater than 99% in both groups.
On the basis of 2 controlled clinical studies, oral bisphosphonate usage was not associated with occurrence of ONJ.
骨质疏松症和骨质减少的特征是骨量减少，可能导致骨骼脆弱和骨折。最新一代口服双膦酸盐药物，包括阿仑膦酸盐和利塞膦酸盐，已被批准用于预防和治疗骨质疏松症。这些药物通过化学方式被吸收进骨骼，减少破骨细胞数量和活性，从而减少骨吸收。本报告的目的是呈现两项针对接受口服双膦酸盐治疗患者的对照研究的安全性数据。
研究1测试了骨吸收抑制剂阿仑膦酸盐对牙槽骨的影响。共有335例（162例男性和173例女性，年龄30至79岁）患有中度或重度牙周病的患者被随机分为安慰剂组或每周一次70毫克阿仑膦酸盐组。在2年期间评估牙槽骨高度和安全性。研究2是一项纵向单盲对照设计，比较了50例连续患者（210颗种植体）、25例接受双膦酸盐治疗的患者和25例年龄匹配的对照受试者的种植成功率。对种植成功率和安全性，包括颌骨坏死（ONJ）的发生率进行了至少3年的盲法评估。
在研究1中，两个治疗组均未观察到ONJ病例。此外，在阿仑膦酸盐组中观察到感染和牙齿脱落发生率有降低的趋势。在研究2中，两组均未观察到ONJ病例，且两组的种植成功率均超过99%。
基于两项对照临床研究，口服双膦酸盐的使用与ONJ的发生无关。
