Bone Loss, Age-relatedPhase 1NCT02349113
Effects of Acute Estrogen Therapy on Bone Formation
A Phase 1 study testing Estrogens (Climara) in people with Bone Loss, Age-related, run by Mayo Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Age-related
- What is being tested?
- Estrogens (Climara)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Bone Loss, Age-related
- Being tested
- Estrogens (Climara)
- Keywords
- estrogen, aging
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estrogens (Climara)Drug
Also called Climara
Treatment with estrogens: Estradiol dermal patch 0.1mg/d transdermally
| Study group | Role | What they receive |
|---|---|---|
| Estrogens | Experimental | Estrogens treatment: Intervention with short course (3 weeks) of treatment with transdermal estrogen (0.1mg/d) Receives: Drug: Estrogens (Climara) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression (RNAseq analysis of gene expression from needle bone biopsies)
RNAseq analysis of gene expression from needle bone biopsies
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Loss, Age-relatedStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sundeep Khosla, M.D., Mayo Clinic
- Investigators
- Sundeep Khosla, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349113
- Sponsor's protocol ID
- 09-001935
- Status last verified
- Feb 2015
- First submitted
- 23 Jan 2015
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26402159
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Estrogen Therapy on Bone Formation
- ClinicalTrials.gov ID
- NCT02349113
- Acronym / sponsor ID
- 09-001935
- Conditions
- Bone Loss, Age-related
- Keywords
- estrogen, aging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Estrogens | Experimental | Drug: Estrogens (Climara)Estrogens treatment: Intervention with short course (3 weeks) of treatment with transdermal estrogen (0.1mg/d) |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estrogens (Climara)Also: ClimaraTreatment with estrogens: Estradiol dermal patch 0.1mg/d transdermally | Drug | Estrogens |
Primary outcome
Gene expression (RNAseq analysis of gene expression from needle bone biopsies)
Time frame: 3 weeks
RNAseq analysis of gene expression from needle bone biopsies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- Derived from this study: PubMed 26402159Farr 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sundeep Khosla, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Estrogens (Climara) in people with Bone Loss, Age-related, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression (RNAseq analysis of gene expression from needle bone biopsies) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02349113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.