ClinicalTrials.gg
RecruitingNCT04704947Updated Jan 12, 2021

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

A Phase 3 interventional study of nonselective beta blocker and cardio-selective beta blocker group in Beta Blocker Toxicity, sponsored by Sherief Abd-Elsalam. Recruiting at 1 site in Egypt. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-01-12.

Sponsored by Sherief Abd-Elsalam · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Oct 2017, registered Jan 2021).
  • Started Oct 2017; still recruiting 9 years 1 month later.
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Beta Blocker Toxicity
03

In context

Lead sponsor

Sherief Abd-Elsalam is the lead sponsor of 50 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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:

  • , Loop diuretics, Anticonvulsants, Antidepressants, Aromatase inhibitors, Thyroid replacement therapy and Proton pump inhibitors.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: nonselective beta blocker · Drug: alendronate sodium

  • Experimental
    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.

    Drug: cardio-selective beta blocker group · Drug: alendronate sodium

  • Placebo comparator
    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.

    Drug: alendronate sodium

Interventions

06

What researchers measure

Primary outcomes

  1. Number of patients with fracture in each group

    the exact number of patients with fracture in each group

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2017 (actual). Primary completion is estimated for Oct 2030, 156 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2021
First posted
Jan 12, 2021
StartActual
Oct 1, 2017
Primary completionEst.
Oct 1, 2030
CompletionEst.
Oct 1, 2030
Last update
Jan 12, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04704947
Lead sponsor
Sherief Abd-Elsalam
Responsible party
Sherief Abd-Elsalam (Ass. Prof. Tropical Medicine, Tanta University) — Sponsor-investigator
First posted
Jan 12, 2021
Start date
Oct 1, 2017
Primary completion
Oct 1, 2030 (estimated)
Completion
Oct 1, 2030 (estimated)
Last update
Jan 12, 2021

Study contacts

Sherief Abd-Elsalam, ass. prof.
Contact
sheriefabdelsalam@yahoo.com
00201147773440
Mona Abd El-Rafea Abdo, PH D
principal investigator · Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drugs tested here: Propranolol · Bisoprolol

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