The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Absolute Change in 24 Hour Urinary Calcium Excretion
研究概览
简要总结
The purpose of this study is to assess if estrogen replacement normalizes urinary calcium excretion in postmenopausal women with hypercalciuria and low bone mass and to assess for differences in response to estrogen replacement in women with familial hypercalciuria compared to nonfamilial hypercalciuria.
详细描述
Subjects will primarily be recruited from the subjects of protocol 12-1421. Subjects may also be identified through chart review of patients seen by Dr. Favus in the Bone Clinic at the University of Chicago. These subjects will be mailed a letter describing the study and a request to contact us if they are willing to participate in the study.
We plan to enroll 20 subjects to obtain complete data on 16 subjects. We aim to have 10 subjects who will have confirmed familial idiopathic hypercalciuria (IH) and 10 subjects who will have no family history of hypercalciuria.
Subjects will be brought into the Clinical Research Center at the University of Chicago where blood samples will be collected by phlebotomy to obtain the following screening tests: complete metabolic panel; including calcium, phosphate, magnesium, creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and albumin; parathyroid hormone, 25-hydroxyvitamin D, follicle stimulating hormone (FSH), and estradiol. A twenty-four hour urine collection starting with second void of the day will be collected for calcium, phosphate, magnesium, citrate, oxalate, sodium, ammonia, sulfate, and creatinine. Subjects on diuretics will be screened after a 2 week washout period, provided this can be discontinued safely. If subjects have participated in study protocol number 12-1421, these screening tests do not have to be repeated and the results from protocol number 12-1421 will be used to determine eligibility.
Screening subjects who meet inclusion criteria can proceed to the observational study. Screening subjects who are vitamin D depleted (serum 25-hydroxyvitamin D less than 35 ng/mL) may be rescreened after repletion of vitamin D.
A letter describing the study aims, protocols, and risks and benefits will be sent to their primary care physicians and gynecologists. Upon completion of the study, a summary letter will be sent as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women
- •Diagnosis of hypercalciuria
- •Diagnosis of low bone mass
- •Vitamin D replete (serum 25-hydroxyvitamin D level >35 ng/mL)
排除标准
- •Secondary causes of hypercalciuria (primary hyperparathyroidism, sarcoidosis, vitamin D excess, malignant neoplasm, and renal tubular acidosis)
- •Other metabolic bone disease (primary hyperparathyroidism, hyperthyroidism, hypercortisolemia, severe gastrointestinal disorders, liver cirrhosis, renal failure (Cr >1.5), active malignancy including multiple myeloma, rheumatological diseases, and Paget's disease of bone)
- •Use of medications affecting bone and calcium metabolism (corticosteroids in the previous 3 months, suppressive dose of thyroid hormone, calcium channel blockers, anti-convulsants, aromatase inhibitors, thiazolidinediones, and cyclosporine A)
- •History of coronary artery disease
- •Breast cancer or suspected estrogen-dependent neoplasia
- •Previous venous thromboembolic event
- •Active liver disease
- •Tobacco use within the past 6 months
- •Negative colonoscopy within the previous 10 years or sigmoidoscopy within the previous 5 years
- •Negative mammogram within the previous 2 years
- •Negative Pap smear within the previous 3 years in women < or = 65 years old with an intact cervix
- •No vaginal bleeding within the prior 5 months.
- •Age > or = 70
- •> or = 20 years since last menstrual period or use of hormone replacement therapy
研究组 & 干预措施
Transdermal estradiol
Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks
干预措施: Transdermal estradiol (Drug)
结局指标
主要结局
Absolute Change in 24 Hour Urinary Calcium Excretion
时间窗: 4 weeks, 8 weeks
0 participants were measured because the study was terminated
次要结局
- Serum Bone Morphogenetic Protein 2(4 weeks, 8 weeks)
- Serum 1,25-dihydroxyvitamin D3(4 weeks, 8 weeks)
- Serum Sclerostin(4 weeks, 8 weeks)