DEPO-PROVERA USE AND BONE MINERAL DENSITY IN YOUNG WOMEN
DEPO-PROVERA USE AND BONE MINERAL DENSITY IN YOUNG WOMEN
批准号:
2203538
负责人:
DELIA SCHOLES
金额:
$23.98万
依托单位国家:
美国
项目类别:
财政年份:
1994
资助国家:
美国
项目状态:
已结题
起止时间:
1994-07-15 至 1998-04-30
关键词:
adolescence (12-20) body physical activity bone density bone metabolism contraceptives data collection methodology /evaluation diet drug adverse effect female human subject longitudinal human study medroxyprogesterone nutrition related tag photon absorptiometry progesterone analog questionnaires statistics /biometry women's health young adult human (21-34)
中文摘要
骨质疏松症和相关骨折是严重和昂贵的公共健康
预计随着我们的老年人的增加,这些问题将大幅增加
人口在增长。女性经历了更高的所有类型的
骨质疏松性骨折。虽然影响骨量保持的因素
是至关重要的,那些影响峰值骨量获取的因素
年龄较小也会影响日后患骨质疏松性骨折的风险。Depo-
注射用醋酸甲羟孕酮(Depo-Provera,DMPA)
黄体酮,最近成为第一个注射避孕药
获得FDA批准在美国使用--这一行动可能会增加DMPA
在这里和国外都可以使用。初步证据表明,从长远来看
服用DMPA的人的骨密度低于不服用DMPA的人。然而,这个问题
没有在大规模流行病学中接受严格的检查
学习。这项研究建议前瞻性地评估
DMPA对绝经前健康女性骨密度的影响。
我们建议进行一项前瞻性的流行病学研究,以了解
175名妇女开始、持续使用和停用DMPA
接受注射的妇女和不接受注射的350名妇女组成的可比组。这个
组别将从以下年龄段的女性HMO参与者中选出
18-39。将使用一个新的门诊自动化数据库来识别女性
接受DMPA注射。HMO成员资格文件将用于
随机选择没有接触DMPA的女性,频率匹配到
暴露妇女的年龄和初级保健诊所。符合条件的女性同意
参与将被跟踪24至36个月。主要结果是,
骨密度(BMD),将通过测量髋部来评估,
AP腰椎和全身钙使用双能X线机
吸光度测定法。在基线检查后,骨密度将在6-
每隔一个月学习一次,直到研究结束。
这项研究的次要目标将是前瞻性地评估影响
DMPA暴露对骨代谢生化指标的影响。
DMPA代表了一种有效、方便和廉价的避孕药
美国女性的选择。及时评估其使用的这一潜在影响
是必不可少的,不仅从采取行动减少
未来骨质疏松的负担,但为了确保这仍然是
可行的避孕替代品。此外,如果对骨密度没有影响
注意到,该产品的一个剩余安全问题可能会被解决
英文摘要
Osteoporosis and related fractures are serious and costly public health
problems that are projected to increase substantially as our elderly
population grows. Women experience a higher incidence of all types of
osteoporotic fractures. Although factors affecting retention of bone mass
are of critical importance, those affecting peak bone mass acquisition at
younger ages also impact upon later risk of osteoporotic fractures. Depo-
medroxyprogesterone acetate (Depo-Provera, DMPA), an injectable derivative
of progesterone, recently became the first injectable contraceptive to
receive FDA approval for use in the US--an action likely to increase DMPA
use both here and abroad. Preliminary evidence suggests that long-term
users of DMPA have lower bone density than non-users. However, the issue
has not received rigorous examination in large-scale epidemiologic
studies. This research proposes to prospectively evaluate the effects of
DMPA on the bone density of healthy pre-menopausal women.
We propose to conduct a prospective epidemiologic study of the effects of
initiation, ongoing use, and discontinuation of DMPA in 175 women who are
receiving injections and a comparable group of 350 women who are not. The
cohort will be selected from among women HMO enrollees between the ages of
18-39. A new outpatient automated database will be used to identify women
receiving DMPA injections. The HMO membership file will be used to
randomly select women who are not exposed to DMPA, frequency matching to
the age and primary care clinic of exposed women. Eligible women who agree
to participate will be followed for 24 to 36 months. The primary outcome,
bone mineral density (BMD), will be evaluated by measurement of the hip,
AP lumbar spine, and total body calcium using dual-energy X-ray
absorptiometry. Following the baseline visit, BMD will be measured at 6-
month intervals until the end of the study period.
A secondary aim of the study will be to prospectively assess the effects
of DMPA exposure on biochemical indices of bone metabolism.
DMPA represents an effective, convenient and inexpensive contraceptive
option for US women. Prompt evaluation of this potential effect of its use
is essential, not only from the standpoint of acting to diminish the
future burden of osteoporosis, but in order to assure this remains a
viable contraceptive alternative. Moreover, if no effect on bone density
is noted, one remaining safety issue for this product may be put to rest
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