Effects of ACEI on Bone Turnover | NCT02377440

Studies
Effects of ACEI on Bone Turnover

NCT02377440

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

Dec 4, 2015Estimated

Enrollment

32Actual

Phase

Not provided

Conditions

Bone Turnover Status in Hypertensive Patients

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Mar 19, 2014

First Submission Date that Met QC Criteria

Feb 25, 2015

First Posted Date

Mar 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2015

Last Update Posted Date

Dec 4, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nahid Rianon, Assistant Professor, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Name	Class
National Aeronautics and Space Administration (NASA)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

32Actual

Measure	Description	Time Frame
Change in serum CTX levels in pg/mL		baseline, 3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nahid Rianon, MD		Houston	Texas	77030	United States
University of Texas Medical School at Houston