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

Primary Purpose

Beta Blocker Toxicity

Status

Recruiting

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

nonselective beta blocker

cardio-selective beta blocker group

alendronate sodium

About this trial

This is an interventional treatment trial for Beta Blocker Toxicity

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sherief Abd-ElsalamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

nonselective beta blocker group

cardio-selective beta blocker group

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of patients with fracture in each group

the exact number of patients with fracture in each group

Secondary Outcome Measures

Full Information

NCT ID

NCT04704947

First Posted

January 9, 2021

Last Updated

January 9, 2021

Sponsor

Sherief Abd-Elsalam

1. Study Identification

Unique Protocol Identification Number

NCT04704947

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

October 1, 2030 (Anticipated)

Study Completion Date

October 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sherief Abd-Elsalam

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Beta Blocker Toxicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

nonselective beta blocker group

Arm Type

Experimental

Arm Description

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.

Arm Title

cardio-selective beta blocker group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

nonselective beta blocker

Other Intervention Name(s)

Inderal

Intervention Description

nonselective beta blocker

Intervention Type

Drug

Intervention Name(s)

cardio-selective beta blocker group

Other Intervention Name(s)

concor

Intervention Description

cardio-selective beta blocker group

Intervention Type

Drug

Intervention Name(s)

alendronate sodium

Other Intervention Name(s)

alendronate

Intervention Description

alendronate sodium

Primary Outcome Measure Information:

Title

Number of patients with fracture in each group

Description

the exact number of patients with fracture in each group

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sherief Abd-Elsalam, ass. prof.

Phone

00201147773440

sheriefabdelsalam@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mona Abd El-Rafea Abdo, PH D

Organizational Affiliation

Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sherief Abd-Elsalam

City

Tanta

ZIP/Postal Code

35127

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

sherief abd-elsalam, ass. prof

Phone

00201147773440

sheriefabdelsalam@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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