The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass
Stopped early · Phase 2
Conditions studied: Hypercalciuria, Hypercalciuria, Familial Idiopathic, Osteopenia, Osteoporosis
In brief
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.
Key facts
- Study ID
- NCT01928082
- Run by
- University of Chicago
- People needed
- 1
- Starts
- 2013-08-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2018-12-10
Who can join
Age: 40 and older, up to 69. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Postmenopausal women
- Diagnosis of hypercalciuria
- Diagnosis of low bone mass
- Vitamin D replete (serum 25-hydroxyvitamin D level >35 ng/mL)
You may not qualify if…
- 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
- Stroke
- 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
Where it is running
- The University of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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