DEPO-PROVERA USE AND BONE MINERAL DENSITY IN YOUNG WOMEN
DEPO-PROVERA USE AND BONE MINERAL DENSITY IN YOUNG WOMEN
批准号:
2203537
负责人:
DELIA SCHOLES
金额:
$19.33万
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
骨质疏松症和相关的骨折是严重和昂贵的公共卫生
随着我们的老年人,
人口增长。妇女经历各种类型的高发病率
骨质疏松性骨折虽然影响骨量保留的因素
是至关重要的,那些影响峰值骨量采集,
年龄越小也会影响日后发生骨质疏松性骨折的风险。Depo-
醋酸甲羟孕酮(Depo-Provera,DMPA),一种可注射衍生物
孕酮,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
在这里和国外使用。初步证据表明,长期
DMPA使用者的骨密度低于非使用者。但问题
在大规模的流行病学调查中,
问题研究本研究旨在前瞻性地评估
DMPA对健康绝经前妇女骨密度的影响
我们建议进行一项前瞻性流行病学研究,
在175名女性中开始、持续使用和停用DMPA,
接受注射的妇女和未接受注射的350名妇女。的
队列将从年龄在以下的女性HMO登记者中选择:
18-39.一个新的门诊自动化数据库将用于识别妇女
注射DMPA HMO会员档案将用于
随机选择未暴露于DMPA的女性,频率匹配至
受影响妇女的年龄和初级保健诊所。同意的合格妇女
将随访24至36个月。主要结果,
骨矿物质密度(BMD),将通过测量髋关节进行评价,
腰椎前后位,双能X线全身钙
吸收测定法在基线访视后,将在6- 10天测量BMD。
直至研究期结束。
本研究的次要目的是前瞻性评估
对骨代谢生化指标的影响。
DMPA是一种有效、方便和廉价的避孕药
美国女性的选择。及时评估其使用的潜在影响
不仅从采取行动减少
未来的骨质疏松症的负担,但为了确保这仍然是一个
可行的避孕方法。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得到解决
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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