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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by University of Chicago.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01928082
First Posted: August 23, 2013
Last Update Posted: August 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
  Purpose
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.

Condition Intervention Phase
Hypercalciuria Hypercalciuria, Familial Idiopathic Osteopenia Osteoporosis Drug: Transdermal estradiol Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass

Resource links provided by NLM:


Further study details as provided by University of Chicago:

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

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Serum estradiol [ Time Frame: 4 weeks, 8 weeks ]
  • Serum total calcium [ Time Frame: 4 weeks, 8 weeks ]
  • Calculated serum ionized calcium [ Time Frame: 4 weeks, 8 weeks ]
  • Calculated tubular resorption of calcium [ Time Frame: 4 weeks, 8 weeks ]
  • Serum 25 hydroxyvitamin D [ Time Frame: 4 weeks, 8 weeks ]
  • Serum parathyroid hormone [ Time Frame: 4 weeks, 8 weeks ]
  • Serum phosphorus [ Time Frame: 4 weeks, 8 weeks ]
  • Serum osteocalcin [ Time Frame: 4 weeks, 8 weeks ]
  • Serum bone-specific alkaline phosphatase [ Time Frame: 4 weeks, 8 weeks ]
  • Serum C-telopeptides of type 1 collagen [ Time Frame: 4 weeks, 8 weeks ]
  • Serum procollagen type 1 N-terminal propeptide [ Time Frame: 4 weeks, 8 weeks ]

Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transdermal estradiol
Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks
Drug: Transdermal estradiol
4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day
Other Names:
  • Vivelle-Dot 0.05 mg/day
  • Vivelle-Dot 0.10 mg/day

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928082


Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Murray J Favus, MD University of Chicago
  More Information

Publications:

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01928082     History of Changes
Other Study ID Numbers: 12-0062
First Submitted: August 20, 2013
First Posted: August 23, 2013
Last Update Posted: August 23, 2013
Last Verified: August 2013

Keywords provided by University of Chicago:
Hypercalciuria, Familial Idiopathic
Hypercalciuria
Osteopenia
Osteoporosis
Postmenopausal women

Additional relevant MeSH terms:
Estrogens
Osteoporosis
Bone Diseases, Metabolic
Hypercalciuria
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Urological Manifestations
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female