Effects of ACEI on Bone Turnover

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

Study Overview

• Status: Completed
• Conditions: Bone Turnover Status in Hypertensive Patients

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Medical School at Houston
    • Houston, Texas, United States, 77030
      • Nahid Rianon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Aeronautics and Space Administration (NASA)

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: February 25, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: ACE inhibitor
• Other Study ID Numbers: HSC-MS-13-0634