The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Postmenopausal women

• Diagnosis of hypercalciuria

• Diagnosis of low bone mass

• Vitamin D replete (serum 25-hydroxyvitamin D level >35 ng/mL)

Exclusion Criteria:

• 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