Atenolol for the Prevention of Osteoporosis (APO)

Phase 2

Active, not recruiting

• Conditions: Healthy
• Interventions: Drug: Atenolol 50 MG; Drug: Placebo

• Registration Number: NCT04905277
• Lead Sponsor: Sundeep Khosla, M.D.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-05-27
• Study Start: 2021-07-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 420

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atenolol	Atenolol 50 MG	Study subjects will take Atenolol 50 mg daily over 2 years
Placebo	Placebo	Study subjects will take a placebo daily over 2 years

Primary Outcome Measures

Name	Time	Method
Primary Outcome: Percent change in femur neck bone mineral density (BMD)	Baseline, 24 months	Percent change in femur neck bone mineral density (BMD) by DXA

Secondary Outcome Measures

Name	Time	Method
Secondary Outcomes: Percent changes in lumbar spine and total hip BMD	Baseline, 24 months	Percent changes in lumbar spine and total hip BMD
Additional secondary outcomes	Baseline, intermediate timepoints, 24 months	Percent changes in radius and ultra-distal radius BMD using DXA and in bone turnover markers (CTx, PINP).

Trial Locations

Locations (3)

MaineHealth; 🇺🇸 Scarborough, Maine, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States