Evaluating beta blockers and fracture risk in osteoporosis patients
Clinical Study Evaluating Selective or Nonselective Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis
PHASE3 · Tanta University · NCT04704947
This study is testing whether different types of beta blockers can help reduce the risk of fractures in older adults with osteoporosis.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Tanta University (other) |
| Locations | 1 site (Tanta) |
| Trial ID | NCT04704947 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the effects of selective and nonselective beta blockers on fracture risk in patients diagnosed with primary osteoporosis. It aims to determine whether these medications influence bone density and fracture incidence in individuals aged 50 and older. The study includes both hypertensive and normotensive patients with significant osteoporosis, as defined by a BMD T-score of -2.5 or lower. Participants will be assigned to receive either a nonselective beta blocker, a cardio-selective beta blocker, or alendronate sodium as part of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are male and female patients aged 50 and older with primary osteoporosis and a BMD T-score of -2.5 or lower.
Not a fit: Patients currently taking medications that improve or worsen osteoporosis, such as corticosteroids or ACE inhibitors, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer medication options for osteoporosis patients, potentially reducing fracture risk.
How similar studies have performed: While there is limited data on the specific use of beta blockers in osteoporosis, similar studies exploring medication effects on bone health have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tanta
- Sherief Abd-Elsalam — Tanta, Egypt (RECRUITING)
Study contacts
- Principal investigator: Mona Abd El-Rafea Abdo, PH D — Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University
- Study coordinator: Sherief Abd-Elsalam, ass. prof.
- Email: sheriefabdelsalam@yahoo.com
- Phone: 00201147773440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Beta Blocker Toxicity