Atenolol for the Prevention of Osteoporosis (APO)

Healthy Clinical Trial

— APO  

Official title:

Beta1-Selective Blockade for Prevention of Postmenopausal Bone Loss: A Phase 2, Multi-Center, Double-Blinded, Randomized Placebo-Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04905277
• Other study ID #: 18-005725
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 27, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Atenolol 50 MG
50 mg Atenolol daily
• Placebo
one placebo daily

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	MaineHealth	Scarborough	Maine

Sponsors (4)

Lead Sponsor	Collaborator
Sundeep Khosla, M.D.	Columbia University, MaineHealth, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome: Percent change in femur neck bone mineral density (BMD)	Percent change in femur neck bone mineral density (BMD) by DXA	Baseline, 24 months
Secondary	Secondary Outcomes: Percent changes in lumbar spine and total hip BMD	Percent changes in lumbar spine and total hip BMD	Baseline, 24 months
Secondary	Additional secondary outcomes	Percent changes in radius and ultra-distal radius BMD using DXA, trabecular and cortical bone microarchitecture at the distal radius and tibia using HR-pQCT and in bone turnover markers (CTx, TRAP5b, PINP, osteocalcin).	Baseline, intermediate timepoints, 24 months