Trial record 12 of 96 for:    estrogen replacement therapy

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01928082
First received: August 20, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum 1,25-dihydroxyvitamin D3 [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Serum bone morphogenetic protein 2 [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Serum sclerostin [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Serum estradiol [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Serum total calcium [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Calculated serum ionized calcium [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Calculated tubular resorption of calcium [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Serum 25 hydroxyvitamin D [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Serum parathyroid hormone [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Serum phosphorus [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Serum osteocalcin [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Serum bone-specific alkaline phosphatase [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Serum C-telopeptides of type 1 collagen [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Serum procollagen type 1 N-terminal propeptide [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 69 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 20, 2013
Last Updated: August 20, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 15, 2014