Bone Turnover Status in Hypertensive PatientsNCT02377440
Effects of ACEI on Bone Turnover
An observational study of Bone Turnover Status in Hypertensive Patients, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
The investigators hypothesize that older persons (≥45 years) treated with ACEI for HTN control will have: i) improved status of bone turnover (decreased P1NP and CTX), and ii) decreased levels of RANKL and RANKL/OPG, compared to those not treated with ACEI and not using RAS-related medications Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Turnover Status in Hypertensive Patients
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to Dec 2015
- Phase
- Observational
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 60 patients (30 men and 30 women) 45 years or older will be recruited at designated outpatient clinics and randomly allocated 1:1 to receive ACEI vs. a non RAS-related antihypertensive medication.
Who may be able to join
- at least 45 years of age
- a diagnosis of (either new or uncontrolled) HTN who will need a new medication for HTN control
- able to consent (no medial issues impairing judgment for consenting based on clinical providers' judgment).
Who cannot join
- younger than 45 years of age
- a diagnosis of metabolic bone disease
- a diagnosis of osteoporosis or use of medication to treat osteoporosis
- a diagnosis of diabetes mellitus, or renal insufficiency, or cancer
- history of allergy to ACEI or ARB, 6) history of use of ACEI or ARB.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nahid Rianon, MD
Houston, Texas, 77030
University of Texas Medical School at Houston
Houston, Texas, 77030
About this study
Official title: Effects of Angiotensin Converting Enzyme Inhibitors (ACEI) on Bone Turnover
The investigators hypothesize that older persons (≥45 years) treated with ACEI for HTN control will have: i) improved status of bone turnover (decreased P1NP and CTX), and ii) decreased levels of RANKL and RANKL/OPG, compared to those not treated with ACEI and not using RAS-related medications
- Keywords
- ACE inhibitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum CTX levels in pg/mL
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Turnover Status in Hypertensive PatientsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA)
- Responsible party
- Principal investigator, Nahid Rianon, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377440
- Sponsor's protocol ID
- HSC-MS-13-0634
- Status last verified
- Dec 2015
- First submitted
- 19 Mar 2014
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Angiotensin Converting Enzyme Inhibitors (ACEI) on Bone Turnover
- ClinicalTrials.gov ID
- NCT02377440
- Acronym / sponsor ID
- HSC-MS-13-0634
- Keywords
- ACE inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA)
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Mar 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.
The investigators hypothesize that older persons (≥45 years) treated with ACEI for HTN control will have: i) improved status of bone turnover (decreased P1NP and CTX), and ii) decreased levels of RANKL and RANKL/OPG, compared to those not treated with ACEI and not using RAS-related medications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 60 patients (30 men and 30 women) 45 years or older will be recruited at designated outpatient clinics and randomly allocated 1:1 to receive ACEI vs. a non RAS-related antihypertensive medication.
Key inclusion criteria (3 listed)
- at least 45 years of age
- a diagnosis of (either new or uncontrolled) HTN who will need a new medication for HTN control
- able to consent (no medial issues impairing judgment for consenting based on clinical providers' judgment).
Key exclusion criteria (5 listed)
- younger than 45 years of age
- a diagnosis of metabolic bone disease
- a diagnosis of osteoporosis or use of medication to treat osteoporosis
- a diagnosis of diabetes mellitus, or renal insufficiency, or cancer
- history of allergy to ACEI or ARB, 6) history of use of ACEI or ARB.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in serum CTX levels in pg/mL
Time frame: baseline, 3 months
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 4 Dec 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Turnover Status in Hypertensive Patients, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
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 3 inclusion and 5 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 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Change in serum CTX levels in pg/mL (time frame: baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2015.