Clinical Study Evaluating Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis
Clinical Study Evaluating Selective or Nonselective Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis
1 other identifier
interventional
50
1 country
1
Brief Summary
Clinical study evaluating selective or nonselective beta blockers use and fracture risk in patients with primary osteoporosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2017
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 9, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2030
January 12, 2021
January 1, 2021
13 years
January 9, 2021
January 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with fracture in each group
the exact number of patients with fracture in each group
1 year
Study Arms (3)
nonselective beta blocker group
EXPERIMENTALTwenty 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
EXPERIMENTALTwenty 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.
Control group
PLACEBO COMPARATORTen patient with osteoporosis on alendronate sodium 70 mg (Fosamax®) once/week, vitamin D3 1 mcg once daily and calcium supplement 500 mg once daily.
Interventions
nonselective beta blocker
cardio-selective beta blocker group
alendronate sodium
Eligibility Criteria
You may qualify if:
- Male \& female osteoporotic patient aged ≥ 50 years
- Hypertensive \& normotensive patients
- BMD T-score ≥ 2.5 or more SD below peak bone mass
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sherief Abd-Elsalam
Tanta, 35127, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mona Abd El-Rafea Abdo, PH D
Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Ass. Prof. Tropical Medicine
Study Record Dates
First Submitted
January 9, 2021
First Posted
January 12, 2021
Study Start
October 1, 2017
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
October 1, 2030
Last Updated
January 12, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share