Atenolol for the Prevention of Osteoporosis (APO)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-27

Study Completion Date

2026-03-31

Brief Summary

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Evaluate whether treatment with a widely used beta blocker, atenolol, will prevent bone loss at the lower back and hip in postmenopausal women.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Atenolol vs. Placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Atenolol

Study subjects will take Atenolol 50 mg daily over 2 years

Group Type EXPERIMENTAL

Atenolol 50 MG

Intervention Type DRUG

50 mg Atenolol daily

Placebo

Study subjects will take a placebo daily over 2 years

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

one placebo daily

Interventions

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Atenolol 50 MG

50 mg Atenolol daily

Intervention Type DRUG

Placebo

one placebo daily

Intervention Type DRUG

Other Intervention Names

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Atenolol

Eligibility Criteria

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Inclusion Criteria

* Able and willing to provide informed consent
* Postmenopausal women (FSH ≥ 16 IU/L) (no menses for at least one year)
* Aged 50-75 years

Exclusion Criteria

* Clinical diagnosis of diabetes mellitus requiring insulin
* Clinically significant abnormality in any of the additional screening laboratory studies
* A1c- ≥8
* Calcium - \> upper limit lab value per site
* AST- 2x upper normal limit
* FSH- \< 16IU/L
* eGFR- \< 45 mL/min/1.73m2 based on creatinine
* CBC- Per PI interpretation of each patient
* Presence of (documented clinical diagnosis of any of the following):

* Significant liver or renal disease
* Malignancy (current diagnosis including myeloma or melanoma)
* Radiation (the site PI will determine eligibility on a case-by-case basis)
* Malabsorption (current clinical diagnosis or actively receiving treatment)
* Hypoparathyroidism (current clinical diagnosis or actively receiving treatment)
* Hyperparathyroidism (current clinical diagnosis or actively receiving treatment)
* Acromegaly
* Cushing syndrome
* Hypopituitarism
* Severe chronic obstructive pulmonary disease
* Pheochromocytoma (current clinical diagnosis or actively receiving treatment)
* History of cardiac failure
* Ejection Fraction \<35% (based on most recent EF within the last 12 months, if available)
* PR interval \> 200 msec on screening ECG or known heart block
* History of bronchospastic disease with treatment (asthma, bronchitis)
* Gastric Bypass
* Parkinson's
* Rheumatoid Arthritis
* Psoriatic Arthritis
* Connective Tissue disease
* Undergoing treatment with any medications that affect bone turnover, including the following:

* adrenocorticosteroids (oral for \> 3 months within the past year or year-round use of inhaled corticosteroid use)
* anticonvulsant therapy for seizures (carbamazepine, phenobarbital, or phenytoin within the previous year) pharmacological doses of: thyroid hormone (causing decline of thyroid stimulating hormone below normal, i.e. \< 0.3 miU/L) bisphosphonates (within the past 3 yrs; if taken orally \>1 month in past 3 years) denosumab, romosozumab, estrogen therapy (does not include creams or suppositories) or treatment with a selective estrogen receptor modulator, or teriparatide/abaloparatide (\> 1 month within the past year); aromatase inhibitors (\>1 month within the past year)
* Current use of digitalis glycosides
* Thiazides (\< 6 months of use prior to screening)
* Current or within the past 3 months use of beta blockers
* Any recent fracture within the past 6 months prior to screening (other than fingers, toes and facial fractures, which are all acceptable)
* Bilateral hip replacements or metal in both hips
* Patients with serum 25-hydroxyvitamin D levels of \< 20 ng/ml, in order to ensure vitamin D sufficiency
* Resting systolic blood pressure \< 115 mm Hg, heart rate \< 55 bpm (average of 3 readings after a 5-minute rest and one minute between readings with an automatic cuff)

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes