- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02349113
Effects of Acute Estrogen Therapy on Bone Formation
February 13, 2015 updated by: Sundeep Khosla, M.D., Mayo Clinic
This study is being done to study age-related bone changes in women.
The investigators know that the major cause of osteoporosis is a shortage of the female hormone estrogen.
This study will look closer at how this shortage of estrogen works to cause a decrease in bone formation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Estrogen (E) deficiency is the major cause of postmenopausal osteoporosis.
Understanding the mechanisms by which E regulates bone metabolism is critical for developing novel approaches to prevent and treat this disorder.
We will focus on defining mechanisms for the age-related decrease in bone formation and the role of E deficiency in mediating this decrease.
We will use novel methods we have developed to examine gene expression in highly purified bone marrow osteoblastic cells.
We will test whether the increase in bone formation previously observed following acute E treatment in women is associated with an increase in markers of Wnt/bone morphogenetic protein (BMP) signaling and/or production and in othe genes related to bone formation by osteoblastic cells.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- At least 10 years postmenopausal; Menopause is defined as no menses for at least 1 year (or documented ovariectomy) and a serum follicle-stimulating hormone (FSH) above 30 IU/L.
Exclusion Criteria:
- Clinically significant abnormality in any of the following screening laboratory studies (to be reviewed and determined by PI or CI) : serum 25-hydroxyvitamin D (see below); phosphorus (minor change outside of normal guidelines is acceptable and does not impact the study); alkaline phosphatase and aspartate transaminase (AST) (minor change outside of normal guidelines is acceptable but not to exceed 50% above normal or ineligible); Creatinine (Cr) (minor change outside of normal guidelines is acceptable but not to exceed a value of 1.2 or ineligible); serum calcium must not exceed upper limits of normal guidelines or subject ineligible; FSH needs to be ≥30; thyroid-stimulating hormone (TSH) needs to be above 0.3 and not > 10;
- Presence of significant liver disease, renal disease, malignancy (including breast cancer and myeloma), malabsorption syndrome, hypoparathyroidism, hyperparathyroidism, acromegaly, Cushing's syndrome, hypopituitarism, severe chronic obstructive pulmonary disease, untreated gallbladder disease, history of myocardial infarction (MI) or stroke, or history of thrombophlebitis or deep venous thrombosis;
- Undergoing treatment with any of the following drugs: adrenocorticoid steroids (3 months or longer at anytime or > 10 days of treatment within the previous 12 months), anticonvulsant therapy (within the previous year), sodium fluoride (any history of treatment with fluoride), pharmacological doses of thyroid hormone (causing decline of TSH below normal), calcium supplementation of more than 1200 mg/d (within the preceding 3 months), bisphosphonates in the past, calcitonin (within the past six months), E therapy or treatment with a selective estrogen receptor modulator (within the past 6 months), parathyroid hormone (PTH) use in the past. Subjects with a clinical history of an osteoporotic fracture (vertebral, hip, or distal forearm) within the previous 3 years will also be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Estrogens
Estrogens treatment: Intervention with short course (3 weeks) of treatment with transdermal estrogen (0.1mg/d)
|
Treatment with estrogens: Estradiol dermal patch 0.1mg/d transdermally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gene expression (RNAseq analysis of gene expression from needle bone biopsies)
Time Frame: 3 weeks
|
RNAseq analysis of gene expression from needle bone biopsies
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sundeep Khosla, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
January 23, 2015
First Submitted That Met QC Criteria
January 27, 2015
First Posted (Estimate)
January 28, 2015
Study Record Updates
Last Update Posted (Estimate)
February 16, 2015
Last Update Submitted That Met QC Criteria
February 13, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Osteoporosis
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Estradiol
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
- Estrogens
Other Study ID Numbers
- 09-001935
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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