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

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

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

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

Conditions
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Beta Blocker Toxicity

Intervention / Treatment
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* Drug: nonselective beta blocker
* Drug: cardio-selective beta blocker group
* Drug: alendronate sodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nonselective beta blocker group<br>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<br>* nonselective beta blocker<br>* Other names: Inderal;Drug: alendronate sodium<br>* alendronate sodium<br>* Other names: alendronate;|
| Experimental: cardio-selective beta blocker group<br>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: cardio-selective beta blocker group<br>* cardio-selective beta blocker group<br>* Other names: concor;Drug: alendronate sodium<br>* alendronate sodium<br>* Other names: alendronate;|
| Placebo Comparator: Control group<br>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<br>* alendronate sodium<br>* Other names: alendronate;|

What is the study measuring?
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Primary Outcome Measures

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