Depo-Provera: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150 CI Users and Matched Controls
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 350
- 试验地点
- 12
- 主要终点
- Changes in Bone Mineral Density in adolescent Depo-Provera Contraceptive
研究概览
简要总结
To evaluate and compare Bone Mineral Density (BMD) in adolescent Depo-Provera Contraceptive Injection (DP150CI) users during depo medroxyprogesterone acetate (DMPA) therapy and following discontinuation of DMPA. Another group electing non-hormonal contraception or abstinence will be recruited as a reference population, across all study sites. The primary variable is BMD, measured by Dual Energy X-ray Absorptiometry (DXA). Secondary variables are: Total Body Composition& Total Body Calcium (TBC), measured by Dual Energy X-ray Absorptiometry (DXA), and surrogate biologic BMD markers. Safety will be evaluated by adverse event reporting, laboratory evaluations, pregnancies, weight and vital signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adolescent females who have had any menses in the 6 months prior to enrollment
- •Must have a negative pregnancy test
排除标准
- •Concomitant medication exclusion use of bone modifying agents, glucocorticoids, heparin, and anticonvulsants
- •Screening Spinal BMD with z score not greater than -2 of matched young normals
结局指标
主要结局
Changes in Bone Mineral Density in adolescent Depo-Provera Contraceptive
Injection (DP150CI) users will be evaluated and compared during depo
medroxyprogesterone acetate (DMPA) therapy and following discontinuation of
DMPA.Another group electing non-hormonal contraception or abstinence is
recruited as a reference population, across all study sites.
次要结局
- Secondary variables are: Total Body Composition & Total Body Calcium (TBC),
- measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD
- markers