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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2030-10-01

Brief Summary

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

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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

Conditions

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Beta Blocker Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

nonselective beta blocker

Intervention Type DRUG

nonselective beta blocker

alendronate sodium

Intervention Type DRUG

alendronate sodium

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.

Group Type EXPERIMENTAL

cardio-selective beta blocker group

Intervention Type DRUG

cardio-selective beta blocker group

alendronate sodium

Intervention Type DRUG

alendronate sodium

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.

Group Type PLACEBO_COMPARATOR

alendronate sodium

Intervention Type DRUG

alendronate sodium

Interventions

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nonselective beta blocker

Intervention Type DRUG

cardio-selective beta blocker group

Intervention Type DRUG

alendronate sodium

Intervention Type DRUG

Other Intervention Names

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Inderal concor alendronate

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No