Beta Blocker ToxicityPhase 3NCT04704947
Clinical Study Evaluating Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis
A Phase 3 study testing nonselective beta blocker, cardio-selective beta blocker group and alendronate sodium in people with Beta Blocker Toxicity, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Clinical study evaluating selective or nonselective beta blockers use and fracture risk in patients with primary osteoporosis Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Beta Blocker Toxicity
- What is being tested?
- nonselective beta blocker, cardio-selective beta blocker group and alendronate sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 1 Oct 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Male \& female osteoporotic patient aged ≥ 50 years
- Hypertensive \& normotensive patients
- BMD T-score ≥ 2.5 or more SD below peak bone mass
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta, 35127
sherief abd-elsalam, ass. prof, 00201147773440, sheriefabdelsalam@yahoo.com
About this study
Official title: Clinical Study Evaluating Selective or Nonselective 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
Read the detailed description
Clinical study evaluating selective or nonselective beta blockers use and if there is fracture risk in patients with primary osteoporosis
- Conditions
- Beta Blocker Toxicity
- Being tested
- nonselective beta blocker, cardio-selective beta blocker group, alendronate sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonselective beta blockerDrug
Also called Inderal
nonselective beta blocker
cardio-selective beta blocker groupDrug
Also called concor
cardio-selective beta blocker group
alendronate sodiumDrug
Also called alendronate
alendronate sodium
| Study group | Role | What they receive |
|---|---|---|
| nonselective beta blocker group | Experimental | 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. Receives: Drug: nonselective beta blocker; Drug: alendronate sodium |
| cardio-selective beta blocker group | Experimental | 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. Receives: Drug: cardio-selective beta blocker group; Drug: alendronate sodium |
| Control group | Placebo comparator | 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. Receives: Drug: alendronate sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with fracture in each group
the exact number of patients with fracture in each group
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Oct 2017
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta Blocker ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Mona Abd El-Rafea Abdo, PH D, Principal investigator, Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704947
- Sponsor's protocol ID
- osteoprosis
- Status last verified
- Jan 2021
- First submitted
- 9 Jan 2021
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating Selective or Nonselective Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis
- ClinicalTrials.gov ID
- NCT04704947
- Acronym / sponsor ID
- osteoprosis
- Conditions
- Beta Blocker Toxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical study evaluating selective or nonselective beta blockers use and fracture risk in patients with primary osteoporosis
Detailed description
Clinical study evaluating selective or nonselective beta blockers use and if there is fracture risk in patients with primary osteoporosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nonselective beta blocker group | Experimental | Drug: nonselective beta blocker, Drug: alendronate sodiumTwenty 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 | Experimental | Drug: cardio-selective beta blocker group, Drug: alendronate sodiumTwenty 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 comparator | Drug: alendronate sodiumTen patient with osteoporosis on alendronate sodium 70 mg (Fosamax®) once/week, vitamin D3 1 mcg once daily and calcium supplement 500 mg once daily. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Male \& female osteoporotic patient aged ≥ 50 years
Key exclusion criteria (4 listed)
- Patients on drugs that may improve osteoporosis disease state such as:
- Corticosteroids, Loop diuretics, Anticonvulsants, Antidepressants, Aromatase inhibitors, Thyroid replacement therapy and Proton pump inhibitors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nonselective beta blockerAlso: Inderalnonselective beta blocker | Drug | nonselective beta blocker group |
| cardio-selective beta blocker groupAlso: concorcardio-selective beta blocker group | Drug | cardio-selective beta blocker group |
| alendronate sodiumAlso: alendronatealendronate sodium | Drug | Control group, cardio-selective beta blocker group, nonselective beta blocker group |
Primary outcome
Number of patients with fracture in each group
Time frame: 1 year
the exact number of patients with fracture in each group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mona Abd El-Rafea Abdo, PH D principal investigator
Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nonselective beta blocker, cardio-selective beta blocker group and alendronate sodium in people with Beta Blocker Toxicity, run by Sherief Abd-Elsalam at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with fracture in each group (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.