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

Sherief Abd-Elsalam

Status and phase: Enrolling; Phase 3

Conditions: Beta Blocker Toxicity

Treatments: Drug: cardio-selective beta blocker group; Drug: alendronate sodium; Drug: nonselective beta blocker

Study type: Interventional

Funder types: Other

Identifiers

NCT04704947

osteoprosis

Details and patient eligibility

About

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

Full description

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

Enrollment: 50 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups, including a placebo group

nonselective beta blocker group

Experimental group

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.

Treatment:

Drug: nonselective beta blocker

Drug: alendronate sodium

cardio-selective beta blocker group

Experimental group

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.

Treatment:

Drug: alendronate sodium

Drug: cardio-selective beta blocker group

Control group

Placebo Comparator group

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.

Treatment:

Drug: alendronate sodium