Effects of Acute Estrogen Therapy on Bone Formation

NCT02349113 | Completed Phase 1

• 1 other identifier: 09-001935
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bone Loss, Age-related

Keywords

estrogen, aging

Outcome Measures

Primary Outcomes (1)

• Gene expression (RNAseq analysis of gene expression from needle bone biopsies)

  RNAseq analysis of gene expression from needle bone biopsies

  3 weeks

Study Arms (1)

Estrogens

EXPERIMENTAL

Estrogens treatment: Intervention with short course (3 weeks) of treatment with transdermal estrogen (0.1mg/d)

Drug: Estrogens (Climara)

Interventions

Estrogens (Climara) DRUG

Treatment with estrogens: Estradiol dermal patch 0.1mg/d transdermally

Also known as: Climara

Estrogens

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Related Publications (1)

• Farr JN, Roforth MM, Fujita K, Nicks KM, Cunningham JM, Atkinson EJ, Therneau TM, McCready LK, Peterson JM, Drake MT, Monroe DG, Khosla S. Effects of Age and Estrogen on Skeletal Gene Expression in Humans as Assessed by RNA Sequencing. PLoS One. 2015 Sep 24;10(9):e0138347. doi: 10.1371/journal.pone.0138347. eCollection 2015.

  PMID: 26402159 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Estrogens; Estradiol

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Sundeep Khosla, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: January 28, 2015
• Study Start: February 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 16, 2015

Record last verified: 2015-02