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

Phase 3

Recruiting

• Conditions: Beta Blocker Toxicity
• Interventions: Drug: alendronate sodium; Drug: cardio-selective beta blocker group; Drug: nonselective beta blocker

• Registration Number: NCT04704947
• Lead Sponsor: Sherief Abd-Elsalam

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

Study Timeline

• Study Start: 2017-10-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-09
• Study First Submitted QC: 2021-01-09
• Last Update Submitted: 2021-01-09
• Study First Posted: 2021-01-12
• Last Update Posted: 2021-01-12
• Primary Completion: 2030-10-01
• Study Completion: 2030-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	alendronate sodium	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.
nonselective beta blocker group	alendronate sodium	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.
cardio-selective beta blocker group	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.
nonselective beta blocker group	nonselective beta blocker	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.
cardio-selective beta blocker group	alendronate sodium	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.

Primary Outcome Measures

Name	Time	Method
Number of patients with fracture in each group	1 year	the exact number of patients with fracture in each group

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Tanta, Egypt