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

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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 st
Sponsor: University of Chicago

Current Primary Outcome: Absolute change in 24 hour urinary calcium excretion [ Time Frame: 4 weeks, 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Serum 1,25-dihydroxyvitamin D3 [ Time Frame: 4 weeks, 8 weeks ]
  • Serum bone morphogenetic protein 2 [ Time Frame: 4 weeks, 8 weeks ]
  • Serum sclerostin [ Time Frame: 4 weeks, 8 weeks ]


Original Secondary Outcome: Same as current

Information By: University of Chicago

Dates:
Date Received: August 20, 2013
Date Started: August 2013
Date Completion:
Last Updated: August 20, 2013
Last Verified: August 2013