Clinical Study Evaluating Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis

January 9, 2021 updated by: Sherief Abd-Elsalam

Clinical Study Evaluating Selective or Nonselective Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis

Clinical study evaluating selective or nonselective beta blockers use and fracture risk in patients with primary osteoporosis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Clinical study evaluating selective or nonselective beta blockers use and if there is fracture risk in patients with primary osteoporosis

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt, 35127
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Male & female osteoporotic patient aged ≥ 50 years

    • Hypertensive & normotensive patients
    • BMD T-score ≥ 2.5 or more SD below peak bone mass

Exclusion Criteria:

  • Patients on drugs that may improve osteoporosis disease state such as:

    • Angiotensin converting enzyme inhibitor (ACEI) or Angiotensin receptor blockers (ARBs), Thiazide diuretic, Nitrates, Spironolactone, Statins.

Patients on drugs that may worsen osteoporosis disease state such as:

• Corticosteroids, Loop diuretics, Anticonvulsants, Antidepressants, Aromatase inhibitors, Thyroid replacement therapy and Proton pump inhibitors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: nonselective beta blocker group
Twenty patients with osteoporosis and hypertension on the same treatment as control group in addition to propranolol (Inderal®) 10 mg once daily titrated as patient's response.
Drug: nonselective beta blocker
nonselective beta blocker
Other Names:
  • Inderal
Drug: alendronate sodium
alendronate sodium
Other Names:
  • alendronate
EXPERIMENTAL: cardio-selective beta blocker group
Twenty patients with osteoporosis and hypertension on the same treatment as control group in addition to bisoprolol (Concor®) 5 mg once daily titrated as patient's response.
Drug: alendronate sodium
alendronate sodium
Other Names:
  • alendronate
Drug: cardio-selective beta blocker group
cardio-selective beta blocker group
Other Names:
  • concor
PLACEBO_COMPARATOR: Control group
Ten patient with osteoporosis on alendronate sodium 70 mg (Fosamax®) once/week, vitamin D3 1 mcg once daily and calcium supplement 500 mg once daily.
Drug: alendronate sodium
alendronate sodium
Other Names:
  • alendronate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with fracture in each group
Time Frame: 1 year
the exact number of patients with fracture in each group
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Investigators

  • Principal Investigator: Mona Abd El-Rafea Abdo, PH D, Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ANTICIPATED)

October 1, 2030

Study Completion (ANTICIPATED)

October 1, 2030

Study Registration Dates

First Submitted

January 9, 2021

First Submitted That Met QC Criteria

January 9, 2021

First Posted (ACTUAL)

January 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 9, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • osteoprosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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